SERACH RESULTS FOR" Manufacturing "
manufacturing site in Songdo, S. Korea recently, reducing production time by up to 30% for the client. With SBL’s adoption of perfusion technology, clients may choose from a more diversified portfolio of manufacturing options. Perfusion is gaining broader biopharmaceutical application at small scale with clinical development, but few companies have reported utilization at large scale for commercial applications to intensify bioprocessing and boost productivity. The ATF perfusion system at SBL allows for the CDMO to cultivate higher cell culture densities (up to 10 fold) whilst retaining high cell viabilities (>98%) at the seed stage (N-1) to enable inoculation of the production bioreactors (15,000L) at higher cell densities and achieve peak cell densities within shorter culture durations. This allows for improved productivity and reduction in production time, a significant benefit to clients. During perfusion mode, ATF works continuously by utilizing hollow fiber membranes to selectively filter growth medium from mammalian cells with alternating flow to return cells to the bioreactor. A diaphragm pump provides the alternating flow and a low shear environment to minimize cell damage. The spent growth medium is discharged, whilst fresh growth medium is continuously added to replace the spent medium at the same rate. The fresh medium allows for continued cell growth and higher cell densities. A perfusion rate up to 3 vessel volumes per day (VVD) is possible at Samsung BioLogics, utilizing three X Cell™ ATF-10 systems (each 11m2) during perfusion mode whilst other bioreactor controls such as volume, temperature, dissolved oxygen, and pH are kept constant. The perfusion cultivation has been developed in full automation mode by integrating the ATF system with the bioreactor control logics so that manual intervention is reduced to a minimum during the cultivation duration. Alternate perfusion systems such as Tangential Flow Filtration (TFF) may also be applied with flexible flow path configurations installed. The ATF system was carefully designed with consultation and support from the vendor. The ATF system (stainless steel filter housing) validation was completed within a six month period including extensive autoclave cycle development and sterility performance testing along with ATF system water and media tests to qualify the operational controls and provide assurance for closed system integrity and sterility. A lower consumable cost is expected with the fully validated stainless steel ATF filter, although single use ATF filter units can also be applied in the future. The ATF system has been successfully applied for cell culture expansion to meet high cell density targets and production compliant with cGMP operations. With this successful implementation of large scale N-1 perfusion, clients can leverage yet another innovative offering to boost their clinical and commercial production capability in addition to the comprehensive array of biopharmaceutical development, manufacturing, and testing services at Samsung BioLogics.
Manufacturing DealIncheon, S. Korea, Wednesday July 31, 2019 – Samsung BioLogics (SBL) and UCB have agreed to an additional drug substance manufacturing deal under which SBL will also produce UCB’s anti-tau candidate to treat progressive supranuclear palsy, pending regulatory approvals. UCB’s anti-tau candidate is currently in Phase I clinical studies. UCB is a biopharmaceutical company, headquartered in Belgium, with over 90 years of innovation focusing on neurology and immunology, with an annual revenue of 4.6 billion EUR in 2018. UCB S.A. is listed on Euronext Brussels. “Our aim at UCB is to help people suffering from severe chronic diseases in areas of high unmet needs, and we need to work with organizations with proven track records to secure world class manufacturing capabilities to bring our future drugs to patients,” said Scott Russell, Head of Partnerships & Alliances at UCB. “Samsung Biologics has proven to be a true partner and we are delighted to be working with them on a third consecutive project to complement our internal resources”. “We are extremely proud to further solidify our partnership with UCB, a company with a rich history and vision to innovate healthcare and patient value. This new agreement will also provide us the opportunity to showcase SBL’s newest facility, Plant 3, and demonstrate our proven track record of operational and regulatory success to enable UCB’s treatment of patients with this debilitating disease,” said Dr. Tae Han Kim, President and CEO of Samsung BioLogics. This will be the third product from UCB to be supplied by Samsung BioLogics under a master services agreement between the parties announced in July 2018. SBL and UCB previously signed two sub-agreements to manufacture UCB’s products currently in clinical development, for addressing the needs of patients effected by myasthenia gravis, psoriasis and psoriatic arthritis.
manufacturing, and research), making it easier to understand the company’s end-to-end business capabilities. Industry professionals and job seekers can also get an insight into the working environment and the numerous benefits offered at SBL, and interested candidates can submit their information to the SBL Talent Pool via the website. “For the past eight years, our company has been on a record-pacing journey of growth and innovation, and as our business capabilities and client services continues to evolve, it is crucial that our clients, prospective candidates, and anyone with a vested interest in Samsung BioLogics be able to quickly find the information they are seeking and understand our value proposition via our website. We are excited to announce that the launch of our new website was enabled by innovative information technology and interface design tailored to optimize end-user experience,” said a company representative.
Manufacturing Partnership Dr. Tae Han Kim, CEO of Samsung BioLogics and Dr. Nader Pourhassan, CEO of CytoDyn INCHEON, S. Korea, 30 May 2019 - CytoDyn Inc., a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications and Samsung BioLogics met at the Samsung BioLogics Songdo headquarters for an official signing ceremony of the manufacturing agreement with Samsung BioLogics that was previously announced on April 2, 2019. The signing ceremony was attended by Nader Pourhassan, Ph.D., CytoDyn’s President and CEO, along with Nitya Ray, Ph.D., CytoDyn’s Chief Technology Officer, and hosted by top management of Samsung BioLogics, including Dr. Tae Han Kim, Samsung BioLogics CEO, along with John Rim, EVP, Head of Contract Manufacturing, James Park, SVP Head of Global Business Development and other members of the Samsung BioLogics leadership team. "We are excited to work with Samsung BioLogics, one of the world's best CMO firms. Given the company has consistently demonstrated an extremely high level of quality assurance, capacity, and cost effectiveness, we expect that we will be able to market our new drug quickly following an expected approval," stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director. “It is important for our shareholders to realize that our partnership with Samsung is the first step in validating what we have accomplished and the future potential for leronlimab,” continued Dr. Pourhassan. “One of our major strategic challenges with leronlimab’s sales potential as a monotherapy (provided we obtain approval) was to ensure we have sufficient large scale biologics manufacturing capacity in place to meet the expected demand and our Samsung agreement now successfully satisfies this long-term strategic requirement,” concluded Dr. Pourhassan. “Samsung BioLogics is very excited to be partnering with CytoDyn to bring this potential blockbuster drug to the market. It is clear that leronlimab and the CytoDyn team have an opportunity to bring significantly improved care to HIV patients around the world. Samsung BioLogics is proud to support this effort by providing a stable supply of only the highest quality product,” said Dr. Tae Han Kim, CEO of Samsung BioLogics. Dr. Nader Pourhassan (Left), CEO of CytoDyn and Dr. Tae Han Kim, CEO of Samsung BioLogics The signing ceremony was capped by a tour of the Samsung BioLogics campus including the Plant 2 VIP showroom and a window tour of Plant 3, Samsung BioLogics’ latest state-of-the-art manufacturing facility optimized for high volume products such as leronlimab. About Leronlimab (PRO 140) The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients and for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling. Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. In the setting of cancer, research has shown that CCR5 like
ManufacturingSpeaker: Kevin Sharp, Business Development Part LeadDate: 6/5(Wed) 16:00lo-cation: Theater 1Summary: Overview of the Samsung BioLogics company story providing insights on its history, technologies, and capabilities in bringing innovative approaches to biologics manufacturing. This session will explain how Samsung’s long, rich history of research and development work, coupled with its quality, technology and innovation, will establish a new global standard for best practices within biopharmaceutical manufacturing. Samsung BioLogics Facility Live ShowTitle: Samsung BioLogics Manufacturing LIVEDate: 6/5(Wed) 11:00, 14:00Presenter: Kevin Sharp We look forward to seeing you at the event. To schedule a meeting, please contact us at email@example.com
manufacturing of DS (drug substance) and DP (Drug Product), Samsung BioLogics promises to provide a faster and better path to IND filings and successful BLAs to clients worldwide. Already established as an industry leading CMO in both capacity and service quality as chosen by clients, Samsung BioLogics now offers a full end-to-end range of services as a CDMO. And with the anticipated launch of its biosafety testing services later this year, Samsung BioLogics is poised to become a true one-stop partner of choice for all clients regardless of size, product phase, or global lo-cation. Samsung BioLogics presenters this year will be Eun Young Yang, head of CDO Business Team, and Kevin Sharp, Business Development. On Wednesday the 6th, Eun Young Yang will explain how Samsung BioLogics can ensure “Faster & Better Services for Clients’ Success to IND and BLA” in the BPI Theater, and Kevin Sharp will provide Samsung BioLogics’ company story through “Innovation in Biologics Manufacturing” in Theater 1, as well as be demonstrating “Manufacturing LIVE” at Samsung BioLogics booth #3501 in which augmented reality (AR) technology will be used to interact with Samsung BioLogics CMO operations in real time. “We are extremely proud of our accomplishments in the relatively short period of time since our foundation eight years ago,” said Dr. Tae Han Kim, CEO. “Our cell line and process development capabilities not only adds a new dimension within our services portfolio, but also offers to our valuable clients the flexibility and advantages of a single end-to-end partner for all CDMO needs. We are humbled to have been chosen by our clients as the top CMO for 3 years in a row, and are eager to showcase for future clients our unrelenting commitment to quality, innovation, and ution excellence as demonstrated by our flawless regulatory approval track record and unparalleled batch success rates.” Samsung BioLogics will be showcasing its end-to-end CDMO capabilities at booth #3501 at BIO International 2019 at the Pennsylvania Convention Center in Philadelphia, PA, USA, June 3rd to 6th.
Manufacturing Organization) business in the future. In 2018, Samsung BioLogics launched its CDO business and within a year secured new drug development projects comprising of eight domestic and overseas companies including GI Innovation, quickly establishing a track record of success as a globally advanced player in terms of speed, price competitiveness, quality, and efficiency. "As Samsung BioLogics provides consistent services for CRO (contract research), CDO (contract development) and CMO (contract manufacturing), biopharmaceutical companies will dramatically reduce costs and time,” said Dr. Tae Han Kim, “We will do our best to help domestic bio-venture companies, including GI Innovation, advance into the global market and commercialize their products through our CDO technology." "Thanks to Samsung BioLogics’ CDMO business, we can overcome the problem of producing high quality clinical test samples, the biggest barrier of bio venture companies,” said Dr. Nam, “We are very positive that global pharmaceutical companies interested in the R&D pipeline of GI Innovation will be able to access global new drug licensing (BLA) and biotech drug business through Samsung BioLogics' CDMO service. Through this collaboration, we wish to demonstrate the win-win model of venture firms and large corporations that the people and the government want.”
manufacturing deal worth at least $31 million with CytoDyn Inc. of the United States. Under the terms of the agreement, Samsung Biologics will produce bio-drugs for the American company.This deal may be increased up to $246 million by 2027 if CytoDyn successfully completes its product development efforts and commences on commercialization.CytoDyn, a Washington-based biotechnology company, is currently developing Leronlimab, an HIV treatment drug. Designated as a fast-track drug by the U.S. Food and Drug Administration, Leronlimab is now under Phase 2 clinical trials and is expected to be valued as much as $1 billion if successfully developed.Dr. Nader Pourhassan, president and CEO of CytoDyn, said, "We are excited to work with Samsung Biologics, one of the world's best CMO firms. Given the company has consistently demonstrated an extremely high level of quality assurance capacity, we expect that we will be able to market our new drugs quickly."Dr. Tae Han Kim, CEO of Samsung Biologics, commented, "We will do our best to help our client firm make a timely launch of its innovative drugs and thereby benefit patients. We will keep working hard to develop new business opportunities, with customer satisfaction as our No. 1 goal.">In March this year, Samsung Biologics won the 2019 CMO Leadership Awards, the award ceremony hosted by the Life Science Leader magazine and Industry Standard Research, for the third consecutive year sweeping all six categories including quality, capacity, stability, professionalism, compatibility, and service.The company was also selected as one of the "Future 50" companies by Fortune in October last year in recognition of its prospects for long term growth and global competitiveness.
Manufacturing Organization (CDMO) based in South Korea, is pleased to announce that Samsung has won CMO Leadership Awards for all six core categories for the third year in a row in the 8th annual CMO Leadership Awards Ceremony presented by Life Science Leader.The company has received CMO Leadership Awards including this year’s awards for the sixth consecutive year since 2013, proving Samsung’s highest quality of biologics manufacturing service to global customers. "The value and importance of the Life Science Leader CMO Awards grows each year. No industry awards are more meaningful than these recognizing the highest level of accomplishment as evaluated by actual customers. An award in any of the categories assessed, including capabilities, compatibility, expertise, quality, reliability and service, adds a clear acknowledgment of the leadership provided by the CMO recipient. Our congratulations to all of this year's CMO Award winners you keep the industry on the path to further success," says Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma.For the 2019 CMO Leadership Awards, Life Science Leader magazine teamed up with Industry Standard Research (ISR) to determine the award recipients. More than 120 contract manufactures were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. Survey participants were recruited from Pharma and Biopharma companies of all sizes and were screened for decision-making influence related to working with contract manufacturing suppliers. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that survey responses are based on actual involvement with contract manufacturers and clear experiential data."Samsung BioLogics is honored to be recognized once again as a top-performing CMO by CMO Leadership Awards, which identifies the reputable partner for global customer’s manufacturing needs. It is a great privilege to achieve the top ranking in all six award criteria for three years in a row and to attest to our solid position as a one-stop CDMO service provider for mammalian biopharmaceutical products through our flexible and state of-the-art facilities,” said TH Kim, CEO of Samsung BioLogic. “We continuously strive to provide quality-driven cGMP manufacturing services and to change the paradigm of biopharmaceutical industry for client and patient satisfaction.”Samsung BioLogics, being responsible from clinical development to commercial manufacturing, aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality products for the patient.
manufacturing of Phase I clinical trial materials.Eutilex, a biotech R&D firm established in 2015 by Dr. Byoung S. Kwon, the world-famous immunologist, was listed on the KOSDAQ market in December last year.The company holds a full range of pipeline drugs from antibody treatment to T cell therapy treatment and chimeric antigen receptor (CAR) t-cell therapy treatment drugs. To accelerate the pace of its commercialization efforts, it has undertaken a number of non-clinical and clinical studies concurrently. Most notably, the company possesses several "first-in-class" and "best-in-class" new antibody drug pipelines, based on its knowledge-based antibody platform.The CDO business is a service developing new drugs under contract and typically involves producing cell lines for clients' candidate drugs under development while establishing the mass-production process and manufacturing of Phase I clinical materials.As the number of small-sized biomedicine firms relying on contract development and manufacturing organizations (CDMOs) for their development and manufacturing needs, the CDO market has grown rapidly at an average rate of 15% a year.Given most CDO businesses are effortlessly transitioned to future contract manufacturing organization (CMO) businesses, companies are taking CDOs more seriously.Samsung Biologics has moved into the CDO business in earnest in 2018 and has signed six new drug development projects with domestic and international partners, gaining track records at a rapid pace.The company has earned a high reputation for speed, price competitiveness, quality, and efficiency from customers with whom it has carried out projects."CDOs are important businesses for us as they can create synergies with CMO businesses. We plan on nurturing CDOs to the world-class level by taking customer's success and customer satisfaction very seriously." said Dr. Tae-han Kim, CEO at Samsung Biologics. "We will spare no effort in helping domestic bio start-ups such as Eutilex move to the global market and commercialize their products quickly.""We have worked hard to bring our high-quality antibody pipelines up to speed to clinical phases," said Kwon of Eutilex. "With the latest signing of the CDO agreement, our non-clinical studies will gather speed and domestic launches of cancer drugs like Keytruda and Opdivo will be moved up."
manufacturing contracts from 25 companies and the company is targeting for more than 12 CMO and 10 CRO/CDO orders by the end of this year. The company also announced that it plans to raise orders for Plant No. 3 – which currently secured 25% of total production capacity – to 50 % by the end of the year.
manufacturing city with 560K liters of bioreactor capacity upon the completion of Samsung BioLogics’ Plant 3. “Through partnership with Samsung BioLogics, Saint-Gobain is strengthening its customer-centric development and supply chain capabilities to better serve the biopharmaceutical and medical industries in Korea. We are excited to play a key role in the advancement of the bio cluster ecosystem in Korea”, said Laurent Guillot, Senior Vice President of Saint-Gobain, CEO of High Performance Solutions. Tae Han Kim, the president and CEO of Samsung BioLogics, said "Samsung Biologics will gain more competitiveness in order to supply its products to customers faster and at lower prices with customized bio fluid systems that is flexible according to products." He added "Samsung Biologics, as the world's leading CMO, will continue to lead the growth of Songdo Bio-Cluster in the future for the development of Korea bio-industry." - The End -
FAQ concerning Securities and Futures Commission (SFC) and IFRS-based accounting1. How did the current accounting issue come about? The financial statements of both Samsung BioLogics (“BioLogics”) and Samsung Bioepis (“Bioepis”) have no accounting issues in regards to their operations. BioLogics established Bioepis as a joint venture with Biogen, USA in 2012. The current accounting issue only derives from a difference in interpretation of the accounting standards in the process of reflecting Bioepis into the books of BioLogics. Since its establishment in 2012, Bioepis had been reflected in the books of BioLogics as a consolidated subsidiary. However, it was converted into an equity-method affiliate when a series of events prompted a change in the value of Biogen’s call option, which in turn affected the controlling power in Bioepis. Accordingly, the Bioepis equity shares held by BioLogics were evaluated at their fair market value, while the value of the Biogen call option was posted as a liability.* Consolidated subsidiary: A subsidiary in which the parent company holds management rights. Its assets, liabilities, sales, and income are all added to or consolidated with those of the parent company.* Equity-method affiliate: The parent company reflects only the income of the affiliate on the parent company’s financial statements in proportion to its equity holdings, without reflecting or consolidating the assets, liabilities, or sales of the affiliate. BioLogics received unqualified opinions from three leading accounting firms in Korea (KPMG, PwC, and Deloitte). Following the financial audits by these three firms, the Securities and Futures Commission (“SFC”) requested the Korean Institute of Certified Public Accountants (“KICPA”) for oversight, which concluded that “no material misstatements have been discovered.” The offering circular for BioLogics’ IPO, along with its financial statements for the relevant years, were submitted to and accepted and approved by the Financial Supervisory Commission (“FSC”), and BioLogics was listed on the Korea Stock Exchange in November 2016. In late 2016, the NGO, People's Solidarity for Participatory Democracy (“PSPD”) filed an inquiry with the Financial Supervisory Service (“FSS”) as to the acceptability of the accounting by BioLogics. It was officially determined to have “no issues” at a meeting for response to the questions related to IFRS. FSS was also represented at the meeting. BioLogics received an audit review starting in April 2017 as the NGO and some politicians requested an audit review by the FSS on the audit reports of BioLogics. Following three sessions with the Accounting Oversight Deliberation Commission (“AODC”) and five sessions of SFC meetings from May 2018, the SFC announced its first decision on July 12. The SFC ordered the FSS to re-conduct its audit review of the accounting treatment in question in 2015. On November 14, the SFC finalized its actions taken based on its second audit review after two sessions of SFC meetings.2. What are the final decisions by the SFC? In its first decision on July 12, the SFC ordered the FSS to re-conduct its audit review as to the appropriateness of the change in the accounting method in 2015 that became the center of the initial controversy. The SFC requested the prosecutors’ investigation of BioLogics and its representative director, recommended the dismissal of the CFO, and called for assignment of independent auditors at the company for three years for not disclosing/or insufficiently disclosing Biogen’s call option in its audit reports. In its final decision on November 14, the SFC adopted a resolution stating that the accounting of Bioepis as a consolidated subsidiary rather than as an equity-method affiliate in fiscal years 2012 and 2013 was “negligence”, and in fiscal year 2014 was “gross negligence”. For 2015 accounting treatment, the SFC concluded that BioLogics intentionally violated the accountin
Manufacturing Organization (CDMO) based in South Korea, announced today that the asset transfer deal related to the call option of Samsung Bioepis signed with US based Biogen will be closed on November 7th. Samsung BioLogics will transfer 9,226,068 shares of Samsung Bioepis to Biogen on November 7th, and Biogen will pay Samsung BioLogics about 759.5 billion KRW, including the amount and interest of the acquired shares. As a result, the asset to be sold and derivative liabilities reflected in the current financial statements of Samsung BioLogics will be deleted and in the fourth quarter of 2018, about 441.3 billion KRW gain associated with disposal of Samsung Bioepis will be reflected in non-operating profit. In addition, the cash and cashable assets of Samsung BioLogics will increase from 477.9 billion KRW (as of the end of June 2018) to 1,237.4 billion KRW and the debt ratio will decrease from 94.6% to 42.6% due to the payment of call option of Biogen. Samsung BioLogics and Biogen agreed on the call option that Biogen could purchase up to 50% -1 stake in Samsung Bioepis at the time of signing shareholders’ agreement for the establishment of a joint venture, Samsung Bioepis, in December 2011. Finally Biogen exercised the call option in June 29th 2018. Tae Han Kim, CEO and president of Samsung BioLogics, said “Through the collaboration with Biogen Samsung were able to achieve such remarkable results in early stage on the biosimilar business” he added “We will strive to remain a successfully joint venture with the global biotechnology company through close consultation as we have entered into a full-fledged joint management system by ending this asset transfer deal” ※ Effect of the call option on Samsung BioLogics’s financial statements [Unit: Billion KRW] Before the call option After the call option Share ratio of Bioepis 94.6% 50% + 1 share Asset to be sold 2,247.8 0 Derivative liabilities 1,933.6 0 Gain associated with disposal of Bioepis 0 441.3 As of the end of June 2018 Cash assets 477.9 1,237.4 Debt ratio 94.6% 42.6% - The End-
Manufacturing Organization (CDMO) based in South Korea, announced today that it has obtained an Authorized Economic Operator (AEO) issued by the World Customs Organization (WCO). The AEO certification is granted by the customs authorities of each country to an excellent company that meets the four core criteria of compliance and internal control based on the World Customs Organization (WCO) export and import supply chain safety management standards. It is an international certification system which will enhance the business environment and further facilitate customs procedures. By acquiring an AEO certification, Samsung BioLogics has been able to reduce inventory costs by speeding up customs clearance including the reduction of inspection rate, elimination of document submission and so on since Oct. 15. In particular, Samsung BioLogics is expected to make contracts more through its improved import and export competitiveness as a global CDMO which imports most raw materials and exports all biopharmaceutical products. Temperature-sensitive biopharmaceutical raw materials can be damaged if the customs procedure is prolonged, and if there is a sudden need for supply of the necessary raw materials, the production schedule may be disrupted. For this reason, smooth customs clearance is essential for the improvement of production competitiveness in the case of the contract manufacturing organization (CMO), which receives mainly raw materials from overseas. Companies that received AEO certification take advantages such as expedited shipment and customs simplification. AEO accredited companies can enjoy the same level of benefits in 19 countries around the world, including the United States, China, and Japan, which have signed the AEO MRA (Mutual Recognition Arrangement) agreement. Samsung BioLogics prepared the certificate with its internal task force (TF) for about 14 months. The TF team documented about 135 supplementary documents and 23 work standards in accordance with the AEO guidelines for the document review. In May of this year, Korea Customs Service and the US Customs Trade Partnership Against Terrorism (C-TPAT) jointly held on-site inspection to examine cargo safety management, security systems, and procedures. The joint inspection team highly evaluated Samsung BioLogics’ employees understanding and uting procedures, systematic access control, personnel management, and information security. Tae Han Kim, President and CEO of Samsung BioLogics, said “With the acquisition of AEO certification, Samsung BioLogics becomes more competitive in global business as rapid customs clearance is available.” He added “We will constantly endeavor for more stable supply chain management and innovate to provide biopharmaceuticals in timely manners for our clients and patients.”
Manufacturing Organization (CDMO) based in South Korea, announced today that it has been ranked on Fortune’s Future 50 list of companies best positioned for strong future growth and breakout growth. The Fortune, in partnership with Boston Consulting Group, created ‘Future 50’ in 2017 and ranked 50 global companies with the best prospects for long-term growth. The result is a composite of scores in four dimensions: Strategy, Technology and Investments, People, and Structure. Alphabet, Netflix, Alibaba Group Holdings were also listed in ‘Fortune Future 50’ along with Samsung BioLogics. Dr. T.H Kim, the president and CEO of Samsung BioLogics, said “Positioned on ‘Fortune Future 50’ proves Samsung BioLogics’ growth potential once again just in 7 years” and he added “Samsung BioLogics will continue to make the full efforts to grow into a world leading biopharmaceutical drug development and manufacturing company that can help not only our customers but also our patients through continuous innovation and global market development.” On the other hand, Samsung BioLogics’ Plant 3 became cGMP ready in October 1st, 2018. Although the company is only seven years old, it became the world’s largest CMO with total bioreactor capacity of 362,000 liters in Plant 1, 2, and 3. In addition, Samsung BioLogics has secured CDMO contracts with 24 companies for 33 products and received 19 global manufacturing approvals as of the end of September. - The End-
Manufacturing Organization (CDMO) based in South Korea, announced today on October 1st, 2018 that its Plant 3, the world’s largest single bio manufacturing plant, has become cGMP ready and started production (OOF, out of freezing) after its successful validation. Despite Plant 3 holds 20% larger capacity and 60% more facilities than Plant 2, Samsung BioLogics finished validation in just 10 months, 2 months faster than Plant 2 validation, utilizing know-hows accumulated from Plant 1 and 2. Samsung BioLogics obtained about 4,500 verification records during the self-validation. Validation is practically the first step for manufacturing approvals and productions as the records filed during this stage are essential to receive global approvals in the future. Samsung BioLogics optimized and eliminated errors by applying accumulated construction and validation data and experiences from plant 1 and 2. As a result, the company was able to minimize the validation period significantly. In particular, about 1,200 samples are gathered daily during the validation stage. If one error occurs, more than a week required for rework and verification. To minimize such errors, Samsung BioLogics has continuously conducted previous best-practice education, standardization of sampling, and deployed experienced employees in the site where error occurs frequently. Because of these efforts, the company has reduced the error rate to as low as 0.02%. In addition, Samsung BioLogics standardized validation documents which enables greatly shortened the time required to create and review documents. Also it took a new approach that verify one device as a representative of many that have the same mechanism. Consequently it decreased by more than 17% from 8 to 6.6 verification documents per device. Dr. T.H Kim, the president and CEO of Samsung BioLogics, said “Plant 3 cGMP ready means that Samsung BioLogics has become the largest bio manufacturing CMO in the world” but “we will continue to go forth to change the paradigm of biopharmaceutical industry with its manufacturing competitiveness” On the other hand, Samsung BioLogics has secured CDMO contracts with 24 companies for 33 products and received 19 global manufacturing approvals as of the end of September. - The End -
manufacturing Drug Substance in Plant 1 and 2, and Drug Products in Plant 1 including 2 EMA DP approvals and one PMDA DP approval. Samsung BioLogics is expecting additional global Drug Substance and Drug Product approvals for both Plant 1 and Plant 2 during the second half of 2018. TH Kim, CEO and President of Samsung BioLogics, said “Samsung BioLogics continues to prove that it possesses the capability to provide End-to-End service from cell line development to fill/finish DP service” and he added that “Samsung BioLogics will keep innovating ourselves to manufacture high quality biologics products for clients all over the world in timely manner”
manufacturing a monoclonal antibody Drug Substance at its first plant. This is a great milestone for Samsung BioLogics as it is another global regulatory agency’ approval in addition to FDA, EMA, and PMDA. With the additional two approvals, Samsung BioLogics has received 14 global manufacturing approvals for 14 biologics products. Samsung BioLogics is continuously receiving approvals at an accelerated rate and the number of global approvals is expected to be reach 30 within this year. Samsung BioLogics also received an approval for its Drug Product manufacturing from EMA. This is the company’s second drug product and third global approval. TH Kim, CEO and President of Samsung BioLogics, said “Samsung BioLogics has grown rapidly during the last seven years with 14 global regulatory agency approvals and 362,000 liters biologics manufacturing capacity” Then he added “We will change the paradigm of the bio industry with innovation and ultimately benefit the patients by providing the biologics drugs in a timely manner at lower cost”
manufacturing plant. Samsung BioLogics has demonstrated that both Plant 1 and Plant 2 are compliant with global GMP standards through receiving 14 global regulatory agency’s approvals including FDA, EMA, and PMDA. Although Plant 2 is 5 times larger and 10 times more complicated, Samsung BioLogics received initial manufacturing approval 6 months faster than Plant 1. This shortened time in construction and period of approval allows our clients to quickly supply their products to the market. With its competitiveness, Samsung BioLogics has won the CMO Leadership Award presented by Life Science Leader in all six core categories for two consecutive years. For the 2018 CMO Leadership Awards, more than 110 CMOs from around the world were evaluated on 23 performance metrics to determine winners in the six categories. Only CMO clients participate in the survey, which enhances the validity of the award. TH Kim, CEO and President of Samsung BioLogics, said “There has been some cases recently where CMO’s failure of receiving approval affects the clients’ drug marketing schedule.” Then he added that “Samsung BioLogics has once again demonstrated that it possesses world class Quality with Data Integrity which is critical to get global approvals. Samsung BioLogics has been striving to establish a system to completely prevent even tiny data errors that may occur during the whole production process of biopharmaceuticals from the establishment of the company and to set it up as a corporate culture. TH Kim also said “We will continue to do our best to continuously innovate ourselves so that clients and patients can receive high quality medical products in a timely manner” Samsung BioLogics will be attending the BIO International 2018 Conference in Boston June 4-7, 2018, as an exhibitor for the 8th year in a row to pursue additional contracts. - The End -
manufacturing, and the biggest & state-of-the-art facility which ensures the customer satisfaction is introduced with details via FiercePharma with the title, ‘What the world’s biggest biologics production plant means for CDMO client satisfaction’ on 21 May, 2018. You could check the whole article by clicking the link below here.
manufacturing companies, announced today that it received ISO 22301 certificate, the international standard Business Continuity Management System(BCMS), as the first Korean pharmaceutical company from BSI(British Standards Institution), a global certification association.ISO 22301 certificate is a comprehensive standard published by the International Organization for Standardization (ISO) that represents the highest level of commitment to business continuity and disaster preparedness. In the case of biopharmaceuticals, the production and supply of biologics is directly linked to the life of patients suffering from serious disease including cancer, so it is crucial to stably produce and recover from the crisis. Accordingly, global pharmaceutical companies consider crisis systems critical and request a high level of crisis response system from their partners. Samsung BioLogics has launched internal task force composed of 16 teams and 22 people and has discovered a total of 573 projected risks for about two years, reflecting global customer’ needs. Ultimately, Samsung BioLogics has established an emergency response scenario by anticipating the internal and external crisis that may happen in order to obtain ISO certification. Furthermore it has also proved that Samsung is able to maintain the continuity of management in a short period of time in case of unexpected emergency such as incident and disaster, by pre-setting and preparing the resources and time required to overcome the crisis. “Through ISO 22301 certificate, Samsung’s quality management ability will be recognized once again and it will be a great help in order to get additional orders,” said TH Kim, CEO of Samsung BioLogics. “Samsung will continue to identify internal and external risks and improve our processes so that we will become a company that leads global standards for crisis response by providing our customers with high service availability and business continuity.” - The END –
Manufacturing Organization (CDMO) based in South Korea, is pleased to announce that it has won all six core categories two years in a row in the 7th annual CMO Leadership Awards presented by Life Science Leader. The company has received CMO Leadership Awards including this year’s awards for the fifth consecutive year since 2013, proving Samsung’s highest quality of biologics manufacturing service to global customers “The awards are in recognition of the highest level of accomplishment that drug development and manufacturing organizations have attained in serving the needs of their biotechnology and pharmaceutical customers and partners,” says Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma. “They are especially meaningful because recipients are only evaluated by the customers they have actually worked with, and include the six critical categories of capabilities, compatibility, expertise, quality, reliability and service. An award in any of these categories adds to the distinction and reputation of CMOs throughout the global drug discovery, development, manufacturing and marketing industries.” For the 2018 CMO Leadership Awards, more than 110 CMOs around the world were evaluated on 23 performance metrics to determine winners in the six categories. “Industry Standard Research is honored to conduct the market research for Life Science Leader’s CMO Awards. ISR’s stringent screening processes and the high caliber of qualification required to participate in our contract manufacturing benchmarking market research means that real customers provide experiential feedback on their involvement with contract suppliers over the past 18 months. This enables users of ISR’s market research to make confident business decisions based on the experiences of their industry peers.” Andrew Schafer, President of Industry Standard Research. "Samsung BioLogics is honored to once again receive the CMO Leadership Award, which recognizes the reputable partner for global customer’s manufacturing needs. Being recognized in all core criteria – capabilities, compatibility, expertise, quality, reliability and service – attests to our solid position as a one stop service provider for mammalian biopharmaceutical products through our flexible and state of-the-art facilities,” said TH Kim, CEO of Samsung BioLogic. “We'll continue to provide quality-driven cGMP manufacturing for flexible and cost-effective services that exceed our customers’ expectations.” Samsung BioLogics, being responsible from clinical development to commercial manufacturing, aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality products for the patient. Samsung BioLogics’ Plant 3 facility was mechanically completed last November. It has 180,000 liters capacity and is expected to be cGMP operational by Q4 2018. -E N D –
manufacturing contract for its Plant 3 facilityAccording to Samsung BioLogics, the approximate value of the contract is 148 million US dollars if the product is successful in the clinic and moves forward with commercial launch.Samsung BioLogics’ Plant 3 facility was mechanically completed last November. It has 180,000 liters total capacity and is expected to be cGMP operational by Q4 2018.TH Kim, CEO of Samsung BioLogics, commented “We are excited to enter into this partnership with a fast growing company and very pleased to be chosen to provide a high quality life-saving product to their patients.”He also added that “As products from our Plant 1 (6 x 5,000L) and Plant 2 (10 x 15,000L) facilities mature, Plant 3 will be utilized to supply those with increasing demand to ensure that we continue to meet our client’s demand. We continue to discuss with multiple biopharmaceutical companies for long term partnership in Plant 3. As such, the utilization rate in Plant 3 may ramp up more quickly than anticipated.”
Manufacturing 2018 conference. Samsung BioLogics received ‘Best CMO in Korea’ award for two years in a row recognizing the achievements of leading the bio-industry’s innovation with quality and speed competiveness. The company also received ‘The Company You need to Watch in 2018’ award recognizing the company that displays high innovative potential in developing faster, cheaper, and better quality bioprocessing solutions and expected to contribute greatly to the bioprocessing scene in the upcoming year. In the 5th Biologics Manufacturing Asia 2018 and the 2nd Bio Logistics World Asia 2018, leaders of global pharma companies including Genentech, Amgen, Lonza, professors, and researchers participate to share their opinion. Nicholas Beaumont, vice president of Quality Assurance team of Samsung BioLogics, participated in the event as a panelist and a facilitator for round table discussions. Nick said “Samsung BioLogics has been recognized in many global events which demonstrates the company’s manufacturing innovation and quality competitiveness”. He added that “Samsung BioLogics will continue to innovate to become the leading global CMO that manufactures the highest quality biologics. Additionally Samsung BioLogics received EMA approval last December, two months after FDA approval for plant 2. Samsung BioLogics said “By utilizing latest world-class facilities to both maximize production efficiency and strive for continual innovation to manufacture high quality biologics with competitive price, Samsung aims to provide a one stop contract manufacturing service and be the best CMO in the world.” Samsung BioLogics’ third plant was completed last November with a capacity of 180,000 liters and will begin operation in the fourth quarter of this year after validation. Upon the operation of its third plant in 2018, Samsung BioLogics is expected to become the world’s largest contract manufacturing organization (CMO) for biologics, with a total production capacity of 362,000 liters. – E N D –
Manufacturing Capacity and Production" issued in 2017 by BioPlan Associate, a bio industry marketing research company, the most important factor for clients to choose CMOs is its ability to ‘stick to schedule’. The reason ‘stick to schedule’ is important is that as the competition in the biopharmaceutical industry is becoming intense, it is important to advance into the market and preempt it. However there are more than 10 steps from CMO contract to tech transfer, inspection and production, which takes more than 4 years. Also the cost for clients during this period is about 20 million to 30 million dollars. Successful certification is the most important factor to stick to schedule as product release gets delayed if approval fails. Samsung BioLogics has significantly shortened the period of approval and allows the clients to quickly supply their products to the market in a timely manner.Samsung BioLogics has received 11 manufacturing approvals from US, Europe, and Japan, which are the top three global bio markets in merely six years since the establishment. The company has won 15 products manufacturing orders from 10 pharmaceutical companies including BMS and Roche. On the other hand, plant No. 3, which was completed last month, has 180K capacity and Samsung BioLogics is expected to become the world’s largest CMO with the total production capacity of 362K liters. Tae Han Kim, CEO and President of Samsung BioLogics, said “Samsung BioLogics has proved once again that it possesses world class capability in quality as well as the production scales” and “We will continue to do our best to continuously innovate ourselves so that clients and patients can received medical products in a timely manner”.
manufacturing systems with the world largest single plant with 150K liters of capacity in addition to its first plant - Continue to prepare to receive more inspections for the Market Expansion [INCHEON, KOREA] October 11, 2017 – Samsung BioLogics announced today that on October 11, 2017 it has been licensed by the US FDA (Food and Drug Administration) for the first monoclonal antibody Drug Substance at its second plant, the world largest single plant. With the first license of its second plant from the FDA, Samsung BioLogics is now able to manufacture commercial Biologics Drug Substance at its second plant in addition to its first plant with 30K liters of capacity, Compared to its first plant which took 25 months to get approval from FDA, Samsung BioLogics has received approval of its second plant from FDA in just 19 months since its GMP ready in 2016. Samsung’s second plant with 152K liters is 5 times bigger and ten times more complicated than its first plant but Samsung saves 6 months to receive the first approval from FDA. And the size of its second plant is one and a half as big as global standard world-cup stadium. Samsung BioLogics has improved production efficiency through the installation of ten bioreactors firstly in the world, breaking industry stereotypes to install and operate only four or six bioreactors on a single bio-manufacturing plant. With total of nine approvals now from FDA, EMA, and PMDA, Samsung has proved that all Samsung facilities are compliant with global GMP standards. “We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said TH Kim, CEO of Samsung BioLogics. “We continue to be dedicated to exceeding the strictest of the quality standards and our customers’ expectations.” Samsung BioLogics aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality product for the patient. Samsung BioLogics has invested USD 740 million in its third plant with a bioreactor capacity of 180,000 liters and expects the construction will be completed by the 4th quarter of this year. Once the third plant with advanced technology including 3D modeling is operational in 2018, Samsung BioLogics is expected to have the world’s largest capacity for a biologics contract manufacturing organization(CMO), with a total production capacity of 362,000 liters. Currently, Samsung BioLogics has the production capacity of 182,000 liters through its first plant with 30K liters of capacity, which started full commercial operation in November 2015, and second plant with 152K liters of capacity, which started operation in February 2016. - E N D - About Samsung BioLogicsSamsung BioLogics is a world class full service provider of quality driven contract process development and cGMP manufacturing to the global biopharmaceutical industry. Established in April 2011, Samsung BioLogics will transform the global healthcare industry over the next decade, through our quality, technology and innovation. Our facilities are custom designed for monoclonal & recombinant production with maximum flexibility. Our end-to-end service includes cell line process and analytical method development, analytical services (characterization, comparability, IPC, lot release & stability), clinical and commercial bulk cGMP manufacturing of drug substance and drug product including Quality Assurance, and Quality Control. Samsung BioLogics is committed to meeting or exceeding worldwide regulatory compliance standards and support for our customers. For additional information about the company, please visit http://www.sam
manufacturing opportunities for plant 3.” He also added that SBL “aims to reach its break-even point this year, as announced during the IPO last year.※ Samsung BioLogics Financial Result 2Q 2017 (Billion won) 2Q 17 1Q 17 QoQ Sales 63.2 107.6 ∆44.4 Operating Profit ∆8.5 3.4 ∆11.9 Net Profit ∆22.1 ∆33.1 11
manufacturing tie-up for Tildrakizumab Dr.Tae Han Kim, CEO of Samsung BioLogics and Anil Kumar Jain, CEO of Sun Pharma at the Signing ceremony in Incheon Samsung BioLogics HeadquarterMumbai, INDIA & Incheon, KOREA - July 04, 2017: Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharmaceutical Industries Ltd” and includes its subsidiaries or associate companies) and Samsung BioLogics announced a strategic long-term manufacturing agreement for Tildrakizumab. The agreement was entered into by Sun Pharma’s wholly-owned subsidiary and Samsung BioLogics. According to the agreement, Sun Pharma has appointed Samsung BioLogics to manufacture Tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis. Filings for this novel investigational biologic has been accepted for review by the U.S. Food and Drug Administration (FDA) (May 2017) and the European Medicines Agency (EMA) (March 2017). The agreement was signed at Samsung BioLogics’ headquarter in Incheon, South Korea. The approximate value of the contract will be US$ 55.5 million, other financial details of the agreement are confidential. Commenting on the development, Dr. TH Kim, President and CEO of Samsung BioLogics said, “Samsung BioLogics is pleased to join hands with Sun Pharma and is looking forward to delivering best-in-class manufacturing services with global quality standards. Our collaboration with Sun Pharma is an important milestone for Samsung as it is a testament of our ability to provide reliable supply through its GMP-certified manufacturing facility to pharmaceutical companies, which aim to expand their global market.” Commenting on its agreement with Samsung BioLogics, Mr Kirti Ganorkar, Global Head – Portfolio Management & Business Development, Sun Pharma said, “Samsung BioLogics is a globally renowned CMO. Through this partnership we will leverage Samsung’s manufacturing knowledge and world class quality systems to provide high quality products for the Tildrakizumab pipeline.”
Samsung BioLogics’ Statement on recent media reportsregarding the Samsung BioLogics’ IPO Samsung BioLogics has prepared a statement regarding recent reports in the Korean media alleging that Samsung BioLogics received preferential treatment from the Korean government during its IPO.1. What is the reason for Samsung BioLogics’ substantial net profit in 2015? Valuation gains resulted from a one-time net profit (non-operating profit) in 2015, as Samsung BioLogics’ subsidiary, Samsung Bioepis, was no longer accounted for as our consolidated subsidiary and instead became an investment in associate, which was initially recognized at fair value and accounted for using the equity-method. At the end of fiscal year 2015, the accounting firm KPMG Samjung believed that Samsung BioLogics should carry out a fair value evaluation under the International Financial Reporting Standards (IFRS) in order to recognize the liabilities related to the call option of Biogen, our joint venture partner in Samsung Bioepis. (Before 2014, we determined that we did not or could not determine Samsung Bioepis’ value). The value of Samsung Bioepis rose greatly due to the successful marketing approval of biosimilars in Korea and Europe in late 2015 and early 2016. Bioepis product approval Enbrel : Korea - October 2015, Europe - January 2016Remicade: Korea - December 2015 Samsung Bioepis is currently valued at KRW 5,272.6 billion, of which KRW 4,808.6 billion is equivalent to 91.2% of Samsung Bioepis shares held by Samsung BioLogics. Taking out the amount already reflected in the financial records, the valuation gain amounts to KRW 4,453.6 billion. Samsung Bioepis’ earnings before interest and taxes (EBIT) is KRW 2,723.2 billion excluding the value of the call option held by Biogen (worth KRW 1,820.4 billion) and KRW 2,064.2 billion is reflected in net profit considering corporate tax. □ Accounting treatment related to Samsung Bioepis at the end of 2015 (in KRW billions) End of 2015CommentsValue of Bioepis5,272.6Valuation amount calculated by Deloitte Anjin (accounting firm) Epis stock valuation gain(a-b)4,543.6 Holding Equity value(a)4,808.6Value of Epis × 91.2% Book value before valuation(b)265 Call option valuation loss(c-d)1,820.4 Value of equity purchase(c)2,172.3Value of Epis × 41.2% Exercise price (d)351.9Payment at the occasion of call option Pre-tax profit2,723.2Non-operating income reflected to the company Corporate tax659.0 Net income2,064.2 Samsung BioLogics did not want to change its valuation method as it could be misleading, due to large-scale valuation gains. However, we accepted a change to the valuation method because we respected the recommendation of our external auditors who advised us that it should be strictly evaluated according to IFRS standards, enhancing accounting transparency as a global company. Deloitte Anjin, our designated external auditor in 2016, determined that the accounting treatment was correct, and the Korea Exchange also considered it appropriate. 2. Why was Samsung Bioepis, a subsidiary company of Samsung BioLogics, changed from consolidated subsidiary to equity-method subsidiary in 2015?It was done in accordance with requirements based on the IFRS, not based on Samsung BioLogics’ choice. Samsung BioLogics changed Samsung Bioepis from consolidated to equity-method subsidiary in its 2015 financial records, upon the request of the accounting firm KPMG Samjung. The change was in line with IFRS corporate accounting standards 1110 B23(3).The reason for removing Samsung Bioepis as a consolidated subsidiary was as follows. For Biogen, a joint shareholder of Samsung Bioepis, the value of the holding shares subject to the call option became greater than the price of exercising the call option (in-the-money) as development results of bi
manufacturing company, was established in 2011 and is currently manufacturing drugs for global pharmaceutical companies such as Roche and BMS under long-term agreements. The company went public on the Korea Exchange on November 10 of this year and recorded the second-largest IPO size in the global biotech sector. The IPO attracted in total $700Mn of foreign investment and enabled the construction of Plant 3 and biosimilar development of its subsidiary, Samsung Bioepis. Samsung BioLogics will continue to strive to become a world-renowned company and enable the bio-industry to become the new growth driver of the nation.
manufacturing organization, has announced the appointment ofJeremy M. Caudill as Vice President of Global Business Development. In his new role, Mr. Caudill has relocated to Korea to join the Samsung BioLogics team and has global responsibilities for all business development & related activities. Tae-Han Kim, Ph.D., CEO of Samsung BioLogics says: “Jeremy brings an exceptional track record of business development in the biopharmaceutical market combined with an extensive network of senior level decision makers. He is an industry leader and brings to Samsung BioLogics an impressive background including broad international experience in business development, which will support us in selling the services of our state-of-the-art 30,000 L plant in Songdo, Korea.” Mr. Caudill has over 15 years of experience in the biopharmaceutical industry. He joins Samsung BioLogics from Oncobiologics, Inc. where he served most recently as Vice President, Strategic Business Development with previous positions at DSM Biologics where he was Global Vice President of Sales, Marketing and Business Development, Lonza and Sigma-Aldrich. He earned a B.S. in Biological Sciences from Indiana University. http://www.marketwatch.com/story/samsung-biologics-announces-new-head-of-global-business-development-2012-05-29
manufacturing work to CMOs, resulting in an increased demand for the CMO industry. In this industry, it is extremely important to accurately read changes in the market, and be able to predict the upcoming trends.From its inception, Samsung Biologics has been thoroughly analyzing the market supply and demand. Based on the analysis, we have predicted a shortage in supply and boldly decided to invest in large scale capacity, which established SBL as a successful player in the Bio CMO market. Through long-term partnerships with global pharmaceutical companies, we have made great achievements within a very short time frame.Last year, Samsung Biologics secured a stable funding structure to support future growth, via its successful IPO. Now, I would like to talk about our latest business achievements. Samsung Biologics has signed nine CMO contracts with six global pharmaceutical companies, and we are currently under negotiations with fifteen pharmaceutical companies to produce over thirty products. Plant 1, which began commercial operation in 2015, was successfully approved by the FDA and EMA, and has been recorded a surplus in operating income since last year. Plant 2, which is the world's largest mammalian cell culture plant, is ramping up to prepare for full production and is expected to also record a surplus in operating income.Plant 3, poised to become the most competitive plant in the world, has recorded construction progress of 70%, will be mechanically complete by Q4 this year, and will begin GMP operation by Q4 next year. Owing to our competitiveness in construction, production, and quality, Samsung Biologics is achieving improved performance in key metrics such as revenue and operating income. Last year, we recorded revenue of 294.6billion won, a 223% increase from the previous year. Samsung Biologics has already become a leading company in the CMO industry, thanks to our hard work these past 5 years. However, we will not stop here. We will challenge ourselves to become a "Game Changer" in the biopharmaceutical industry. We will bring up the share of CMO production in the biopharmaceutical market from 25% to 50%.2017 will be a very important turning point.Samsung Biologics will make sure to achieve top client satisfaction and innovation in productivity through our "Breakthrough-21 Management Innovation" activities.Also, we will expand our business portfolio to encompass Contract Development Organization R&D services which will reinforce Samsung BioLogics’ technology capability for a sustainable growth. Samsung Biologics strives to increase the value for our shareholders by pursuing sustainable growth and high profit margins in a fast-growing global biopharmaceutical market.Also, as a newly listed public company, Samsung Biologics will contribute to national economic development through transparent and ethical management, and to our national and local community through creating high-value-adding jobs. We ask for your continued support this year, and promise that we the employees will return the favor with enhanced value for our shareholders. Lastly, I ask for your cooperation in making today's assembly a productive one. Thank you. Respectfully yours, Tae Han KimPresident & CEO, Samsung Biologics Co., Ltd
company based in South Korea, is pleased to announce that it has been recognized
with a CMO Leadership Awards presented by Life
Science Leader magazine for the fourth consecutive year since 2013.
manufacturing business.Samsung BioLogics said today sales of 2016 reached 294.6 billion won in the first earning report since a successful initial public offering(IPO), Nov. 10 last year.It posted 30.4 billion won in operating loss. Sales increased 223%, and operating loss improved 85% in 2016 over 2015. According to the net loss, Samsung BioLogics reflected a one-time factor, non-operating income of 2.7 trillion won as a result of revaluation of our 91.2% stake held in Samsung Bioepis in 2015.The results are mainly affected by two factors below in CMO business. 1) First Plant is fully operating 2) Second Plant started trial production ※ Company’s overall rate of operation has been increased As SBL's first plant became fully operational for the CMO business and its second plant initiated trial production, Samsung Biologics' sales reached 295.6 billion won, 223 percent increased from the previous year's 91.3 billion won. Also the company's operating loss decreased 30 percent. Samsung BioLogics expects to improve its performance as the first plant will maintain fully operational and the second plant will gradually increase the rate of operation in 2017. On the other hand, it has completed 60 percent of the construction of its third plant and plans to finish building it by the end of this year.Once the third plant is finished, it is expected to be the world largest one. - END -
Manufacturing Practice (GMP) Compliance of a Manufacturer for Biologics Drug Substance and Drug Product from the European Medicines Agency (EMA). This certification is in addition to the initial US FDA license for the manufacture of Biologics Drug Substances received in November 2015 for Samsung BioLogics’ facility based in Incheon, Korea. The EMA certificate issued in July 2016 is for the production of 3 monoclonal antibody Drug Substances and a Drug Product. Samsung BioLogics has been licensed by the FDA for an additional 2 monoclonal antibody Drug Substances in August 2016 following the first license in November 2015. With the certification and licenses from the EMA and FDA respectively, Samsung BioLogics is manufacturing commercial Biologics Drug Substance and Drug Product in just five years since its launch in 2011. “We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said TH Kim, CEO of Samsung BioLogics. “We can expect and are prepared to receive more inspections from various other regulatory agencies such as those in Japan, Russia, and so on this year.” Samsung BioLogics aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality product for the patient. Samsung BioLogics is investing USD 730 million in its third plant with a bioreactor capacity of 180,000 liters. Once the third plant is operational in 2018, Samsung BioLogics is expected to have the world’s largest capacity for a biologics contract manufacturing organization (CMO), with a total production capacity of 362,000 liters. Currently, Samsung BioLogics has the production capacity of 182,000 liters through its first plant with 30K liters of capacity, which started full commercial operation in November 2015, and second plant with 152K liters of capacity, which started operation in February 2016. - E N D – About Samsung BioLogics Samsung BioLogics is a world class full service provider of quality driven contract process development and cGMP manufacturing to the global biopharmaceutical industry. Established in April. 2011, Samsung BioLogics will transform the global healthcare industry over the next decade, through our quality, technology and innovation. Our facilities are custom designed for monoclonal & recombinant production with maximum flexibility. Our one stop services include cell line process and analytical method development, analytical services (characterization, comparability, IPC, lot release & stability), clinical and commercial bulk cGMP manufacturing of drug substance and drug product including Quality Assurance, and Quality Control. Samsung BioLogics is committed to meeting or exceeding worldwide regulatory compliance standards and support for our customers. For additional information about the company, please visit http://www.samsungbiologics.com.
manufacturing, and more. BIO International Convention will be taking place at Pennsylvania Convention Center, Philadelphia, PA on June 15th - June 18th. If you would like to visit us during BIO International Convention, please visit our booth #3607 located in the Bio Process Zone.If you are interested in establishing a meeting, please contact Jabin Yun at firstname.lastname@example.org.
manufacturing, and more. BIO International Convention showcases over 125+ sessions along with 15 topic areas with over 25,000 BioPartnering meetings. BIO International Convention will be taking place at McCormick Place Convention Center, Chicago, IL on April 22nd - April 25th. Click here for more detail. If you would like to visit us during BIO International Convention, please visit our booth # 4475 located in the Bio Process Zone. If you are interested in establishing a meeting, please contact Min Park at email@example.com.
manufacturing company- Will continue to strengthen its presence in the rapidly growing global biopharmaceutical market [INCHEON, KOREA] April 28, 2016 - Samsung BioLogics on Thursday announced plans for an initial public offering on the KOSPI (Korea Composite Stock Price Index) this year, following a resolution at the Board of Directors. Through the IPO, Samsung BioLogics will be able to secure funds for investments and research into technology innovation as it aims to become a global top-tier biopharmaceutical manufacturing company. Samsung BioLogics will select lead managers for the IPO next month to decide on the exact timing of the listing and the volume of shares to be offered. "We are pleased with our sustainable expansion through continuous investments and innovation,” said Dr. TH Kim, CEO of Samsung BioLogics. "We will continue to strengthen our competitiveness in order to deliver long-term growth and create meaningful value to our customers and shareholders.” The global biopharmaceutical industry is expected to expand to almost $278 billion by 2020, with an annual growth rate of more than 8% on average, according to a World Preview 2015 report by research firm Evaluate Pharma, amid an aging population and the development of medical technology. Samsung BioLogics aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency. Samsung BioLogics is investing a total 850 billion won in its third plant with a capacity of 180,000 liters, which is expected to be completed by 2017 and begin operation in the fourth quarter of 2018 after validation. Once in operation in 2018, Samsung BioLogics is expected to become the world’s largest contract manufacturing organization (CMO) for biologics, with a total production capacity of 360,000 liters. These materials are not an offer for sale of the securities of Samsung BioLogics Co., Ltd. in the United States. The securities may not be offered or sold in the United States absent registration with the U.S. Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended. Samsung BioLogics Co., Ltd. does not intend to register any offering in the United States or to conduct a public offering of securities in the United States. Not for distribution in the United States.
manufacturing organization, has received multiple CMO Leadership Awards in 2016. The company has been honored in a total of four out of five categories, includingQuality, Capabilities, Reliability and Compatibility for both Overall (big and small pharma) as well as Reliability and Compatibility for big pharma. Hosted by Life Science Leader, the CMO Leadership Awards Ceremony and Reception was held at W Hotel in New York. Many Pharma and BioPharma utives and leaders were in attendance. Samsung BioLogics was represented by Ms. Jenifer Wheat, Vice President of Global Business Development in celebration and to highlight the company’s successful expansion as a leading global CMO. At the Awards event, Samsung was also recognized as winner of additional Individual Attribute awards in four categories including Accessible Senior Management, State-of-the-Art, Right the First Time, and On Time Delivery. Samsung BioLogics, established in 2011, has provided innovative and unique services with flexibly designed facilities for cost effective production of monoclonal and recombinant drug substance and drug product. In less than five years from its inception, the company received official approval for production from the U.S. Food and Drug Administration, following successful construction and operations of Plant #1 (30,000L) and Plant #2 (150,000L) located in Incheon, South Korea. Notably, the company celebrated the groundbreaking of its third plant in December 2015 (180,000L), with a total investment of 850 billion won, which will eventually double its biologics manufacturing capacity. Once the third plant begins operation in 2018, Samsung BioLogics expects to become the world’s largest biologics contract manufacturing organization with a total production capacity of 360,000 liters. Samsung BioLogics President & CEO Dr. TH Kim commented: “We are very pleased to receive recognition for our services from leading global pharmaceutical companies. With sustainable growth and successful installation of Quality systems, Samsung BioLogics has become a preferred strategic manufacturing partner to global big pharmas. With the world’s best manufacturing facilities providing full service clinical to commercial drug substance and drug product, we will put our utmost effort to maximize customer satisfaction.” "Each year, the CMO Leadership Awards recognize the success that individual drug development and manufacturing organizations have in serving the needs of their biotechnology and pharmaceutical customers and partners," says Louis Garguilo, utive Editor, Life Science Leader magazine and OutsourcedPharma.com. "Recipients are evaluated by the utives and managers at the sponsors the CMOs have worked, in the 5 critical categories of Capabilities, Compatibility, Expertise, Quality, and Reliability. An award in any of these categories adds to the distinction and reputation of CMOs within the greater drug discovery, development, manufacturing and marketing industries."
manufacturing organization (CMO) with a total production capacity of 360,000 liters. "We are investing in a third plant to provide a stable supply of biopharmaceuticals, a market which is growing exponentially, and to meet the manufacturing demands from global biopharmaceutical companies," said Dr. TH Kim, CEO of Samsung BioLogics. "With the world’s largest capacity and the capability to operate 365 days a year non-stop, the third plant will boast world-class quality and productivity. " Once the third plant is in full operation, Samsung BioLogics expects it will be able to reach 2 trillion won in annual sales and 1 trillion won in operating profit. In the longer term, the company plans to continuously expand its CMO business with further investments planned for 4th and 5th plants. Samsung BioLogics' first plant has recently received official approval for production from the U.S. Food and Drug Administration, and its second plant is scheduled to begin operation in early 2016.
Manufacturing with Merck Millipore. (August 20, 2014) – Samsung BioLogis announced today that Samsung BioLogics and Merck Millipore signed an MOU (Memorandum of Understanding) for a strategic alliance on the biopharmaceutical business. The alliance is intended to encompass a long-term supply agreement in which Merck Millipore will provide raw materials for biopharmaceutical manufacturing.Dr. Udit Batra, President and CEO of Merck Millipore, and Benoit Gourdier, head of Merck Millipore’s Process Solutions Asia, were present at the signing ceremony held at Samsung BioLogics’ headquarters in Korea. “Our latest partnership in the biopharmaceutical sector will further strengthen the great relationship Merck and Samsung have built in other business areas for the past years. It will also help us support Samsung’s initiative in the CMO and biopharmaceutical field,” said Dr. Batra.Merck will become an essential raw material supplier for Samsung BioLogics’ 30KL facility as well as its new 150KL new facility that is expected to be completed in 2015 at Songdo, Incheon, Korea.“Samsung BioLogics is delighted to develop a strategic alliance with Merck, which will not only provide us a stable supply of crucial raw materials but also bring mutual advantages for both companies’ long-term business strategies and competitiveness in the biopharmaceutical industry,” said Dr. TH Kim, President and CEO of Samsung BioLogics.About Samsung BioLogicsSamsung BioLogics is a global full-service provider of quality-driven contract process development and cGMP manufacturing to the global biopharmaceutical industry. Our facilities are custom designed for monoclonal & recombinant production with maximum flexibility. Our one-stop services include cell line generation, process and analytical method development, analytical services, clinical and commercial bulk cGMP manufacturing of drug substance and drug product including quality assurance, quality control, regulatory compliance standards & support for our customers. For additional information about the company, please visit http://www.samsungbiologics.com.About MerckMerck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.About Merck MilliporeMerck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers’ success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science.Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 66 countries and 2013 revenues of € 2.6 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada.Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany.
Manufacturing Agreement (NEW YORK & SEOUL, South Korea – April 22, 2014) - Bristol-Myers Squibb Company (NYSE:BMY) and Samsung BioLogics today announced the companies will increase the scope of their existing manufacturing agreement in which Samsung will manufacture commercial drug substances and drug product for several Bristol-Myers Squibb biologic medicines at its Incheon manufacturing site. Financial terms of the agreement are not disclosed.Bristol-Myers Squibb and Samsung announced their first manufacturing agreement in July 2013 to collaborate in the production of a single commercial antibody cancer drug substance. "Biologic medicines that treat serious diseases are an integral part of Bristol-Myers Squibb’s specialty care portfolio and R&D pipeline," said Lou Schmukler, president, Global Manufacturing & Supply. "The expanded relationship with Samsung will increase our biologics manufacturing capability and give us the flexibility to respond to increased demand in order to meet the global needs of patients." "Samsung is delighted to reach the second manufacturing agreement with Bristol-Myers Squibb and we look forward to delivering top quality GMP production," said Dr. TH Kim, president and CEO of Samsung BioLogics. "It represents another significant step for Samsung and Bristol-Myers Squibb in strengthening our biopharmaceutical manufacturing relationship." Samsung brings global biopharmaceutical capability through its fully-integrated production facilities that offer process development, drug substance manufacturing, and drug product fill & finish services at one location. In addition to its current biologics manufacturing facility in Incheon, Korea, the company is currently building a second facility, also in Incheon, which is expected to be completed in early 2015. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on twitter at http://twitter.com/bmsnews. About Samsung BioLogics Samsung BioLogics is a global full-service provider of quality-driven contract process development and cGMP manufacturing to the global biopharmaceutical industry. Our facilities are custom designed for monoclonal & recombinant production with maximum flexibility. Our one-stop services include cell line generation, process and analytical method development, analytical services, clinical and commercial bulk cGMP manufacturing of drug substance and drug product including quality assurance, quality control, regulatory compliance standards & support for our customers. For additional information about the company, please visithttp://www.samsungbiologics.com Contacts Bristol-Myers Squibb Media:Laura Hortas, 609-252-4587, firstname.lastname@example.orgKen Dominski, 609-252-5251, email@example.com Investors:Ranya Dajani, 609-252-5330, firstname.lastname@example.orgRyan Asay, 609-252-5020, email@example.com Samsung BioLogics Media:Jabin Yun, +82-32-455-3714, firstname.lastname@example.orgHoyeol(James) Yoon, + 82-32-455-3700, email@example.com
manufacturing agreement under which Samsung will manufacture Roche;s proprietary commercial biologics medicines at its two manufacturing facilities in Incheon, South Korea, of which one is currently under construction.Terms of the agreement will not be disclosed, including financial terms and products to be manufactured.For more informations, please enter the following address.http://www.samsungvillage.com/blog/2013/10/samsung-biologics-signs-a-strategic-manufacturing-partnership-with-roche.html
Seoul(Korea) July 29th, 2013 – Samsung BioLogics and Bristol-Myers Squibb Company announced the companies have entered into a 10-year agreement under which Samsung BioLogics will manufacture a commercial antibody cancer drug for Bristol-Myers Squibb at its recently completed plant in Songdo Incheon, South Korea.Financial terms were not disclosed. Technology transfer and trial production will commence in July 2013. For more informations, please enter the following address.http://news.bms.com/press-release/partnering-news/bristol-myers-squibb-and-samsung-biologics-announce-biopharmaceutical-
manufacturing market.BIO-Europe 2011 in Duesseldorf marks the introduction of Samsung BioLogics to potential partners in Europe. The company’s worldwide tour began at the bio event in the United States in June and included the BIO Japan 2011 world business forum this month in Yokohama.Ahead of BIO-Europe, Partnering news spoke with Tae-Han Kim, CEO of Samsung Biologics, in order to provide insights into the company’s strategy.
Samsung BioLogics (hereinafter, the “Company”) values users’ personal information, complies with statutory obligation s on protection of personal information such as the Act on Promotion of Information and Communication Network Utilization and Information Protection, etc. and the Act on Protection of Personal Information, and has created a Policy to Handle (Process) Personal Information to protect the users’ right and interest to the maximum extent possible.
Through the Policy to Handle (Process) Personal Information, the Company publicizes its operations on personal information treatment (processing) with particulars such as the types of personal information collected from the users and the purpose of processing such information, the time limit for processing and holding in possession, users’ method to exercise their rights, measures to procure the security, and so on.
Whenever there is a change in the Policy to Handle (Process) Personal Information, including updating, deleting, or adding its contents, whether resulting from any amendment to the relevant statutory sources or the administrative policy or change in the Company’s internal policy, we will post the change on our website at www.samsungbiologics. com so as to keep the users updated.
The Company’s Policy to Handle (Proce ss) Personal Information contains the following:
The Company collects personal information for the following purposes. The pfi will not be used for any other purpose and whenever it is necessary to change the purpose, we will comply with the statutory requirements such as obtaining users’ consents in advance.
Review and reply to the inquiries from users
Check employment history, give notices for future recruitment opportunities.
|Required||Name, Email Address, Company, Occupation, Country, Areas of Interest|
|Optional||Job Title, Phone Number|
The following information may be generated and collected in the course of using the service.
Access long, cookie
Collection through Contact Us, Talent Pool within the Website
Collection through generated information collection tool (for access long, cookie, etc.)
Personal information that needs to be collected and utilized inevitably as specifically required by law or regulations, or in order to comply with statutory requirements : As long as it is necessary to keep such information in possession under relevant statute.
Personal information that needs to be collected and utilized inevitably in order to execute and perform various contracts: Until the purpose of collection/utilization is accomplished.
Personal information collected and used with the consent of individual user: For the time period consented to.
If the user has given his/her consent in advance.
If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements, or if it is deemed necessary for the sake of life, body or property of the information owner or a third party when the information owner or his/her legal representative is under a state incapable of communication or unable to give consent due to unknown domiciles or otherwise (only to the extent the purpose of collecting personal information is served).
User’s personal information
History of the users personal information being utilized or provided to a third party
History of consents given to collection, utilization and provision of personal information
If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements.
If it is likely to jeopardize a person’s life or body or unjustly infringe a person’s property or other interests.
The Company is operating cookies that regularly stores and locates users’ information.
How to install cookies (if using Internet explorer 8.0) Select “Internet Option” in the “Tool”. Click “Privacy” tab. Using “Setting”, users may set the level of allowing cookies as suitable for their own needs.
How to view the cookie received (if using Internet explorer 8.0)
Select “Internet Option” in the “Tool”. Click “General” tab and select “Setting” of the Browsing History to check the files in “View Files”.
How to disallow cookie installation (if using Internet explorer 8.0) Select “Internet Option” in the “Tool”. Click “Privacy” tab. Using “Setting”, set it to the higher level, that is, “Block All Cookies”
in handling users’personal information, the Company endeavors to keep the personal information from being lost, stolen, revealed, tampered or damaged. To this end, the following technical and managerial actions are taken.
The Company implements its own internal management plan to secure safety in processing the personal information.
The Company is operating an internal organization dedicated to personal information protection to monitor the status of compliance with the personal information protective requirements and the responsible staff’s duty performance and takes corrective measures when any irregularity is found.
Installation and operation of access restriction device Using the intrusion blocking system, the Company controls any unauthorized access from outside and endeavors to procure all the technological system to the maximum extent feasible in order to secure systematic security.
Minimized designation of personal information processors and education The Company minimizes designation of personal information processors and implements internal and/or outsourced education on a regular basis. Personal information processors’ duty handover is conducted with the security fully maintained and their responsibilities for any personal information accident are clearly defined even after they have left the Company.
Restrictions on access to personal information The Company places restrictions on access to personal information through granting, changing or revoking the right to access to database system that processes personal information. We also record the history of granting, changing or revoking the right, which are retained for our records for at least three years.
The personal information of users is protected by the password and the file and transmission data are encrypted or stored by using file lock function. More important data are protected through certain separate security measures.
The Company has adopted security devices that enable safe transmission of personal information on the network using encryption algorithm.
To safeguard personal information from leak or loss by hackers or computer viruses, the Company has installed a security program and conducts periodic updating and reviewing.
For unmistakable security operation, every server is installed with intrusion blocking system as a means to block outsider intrusion by hacking as well as a system to analyze vulnerability.
To protect users’personal information and handle personal information-related customer complaint, the Company has appointed a personal information manager and processor. Any inquiry related to personal information protection and management should be directed to the personal information processor for instant and adequate reply.
Division: General Affairs Security Part, Personnel Management Team
Any user seeking to relief from personal information infringement may apply for resolution or consultation to Personal Information Dispute Mediation Committee, Korea Internet and Security Agency (Personal Information Grievance Center). In addition, users may contact the following institutions to be consulted on personal information infringement cases.
Personal Information Dispute Mediation Committee (118)
Korea Internet and Security Agency (Personal Information Grievance Center)(www.kopico.or.kr/1336)
Information Protection Mark Verification Committee (http://eprivacy.or.kr/02-580-0533~4)
Internet Crime Investigation Center of the Supreme Prosecutors’ Office
Cyber Police Agency (www.police.go.kr/1566-0112)
Personal information Protection Committee (http://privacy.kisa.or.kr/kor/main.jsp)/02-2180-3000)
When this ‘Policy to Handle (Process) Personal Information’ needs to be changed to reflect the change in statutory sources or government policies, we will put such change in public notice through an advisory statement and a separate window on the website.
Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.