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Research and Development at Enzolytics. “This partnership marks a pivotal milestone for Enzolytics to significantly advance the clinical development of our universal, durable, broadly neutralizing Monoclonal Antibodies and reduce time to the clinic and offer the much-needed treatment for patients."
Biologics are complex, large-molecule substances* that require controlled processes and up-to-date technology to develop. An excellent understanding of the scientific, logistical, and regulatory challenges is also essential for the successful development of biologics to reach product approvals before going into large-scale manufacturing. With considerable challenges to safely and effectively develop biologics, many biopharmaceutical companies are choosing to outsource their development processes to CDO partners. In response to the increasing demand of biologics, Samsung Biologics now not only holds the world’s largest biomanufacturing capacity, but also offers contract development services, establishing the company as a one-stop CDMO service provider. In October 2020, Samsung Biologics opened its first R&D Center in San Francisco, at the heart of the leading U.S. bio-cluster, to be in close proximity to clients as the next door CDO partner. In this article, we will explore the services a CDO partner provides and the unique capabilities Samsung Biologics can bring for a molecule’s success.*Refer to “A New Era in Biotechnology: What are Biomedicines?” Contract Development Services to Expedite Success for Your MoleculeThe development of new drugs is divided into two different stages: the ‘discovery’ stage where a candidate molecule for a specific disease is discovered and the ‘development’ stage which includes all the processes that are required to reach clinical trials and gain product approvals. Contract Development Organizations (CDO) provide the ‘development’ part of the service required for the overall development of new drugs.
research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Bringing quality-driven development services at a greater speed, the company delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.
research and discovery of new treatments, while ensuring development and commercialization of existing products is done reliably. Outsourcing also allows companies to save heavily on investment costs to expand their own development and manufacturing facilities. Biopharmaceuticals: The Journey for Successful Manufacturing Single of CMO Contract Tech Transfer Engineering Run Process Validation Run Application for Approval from Regulatory Agency CMOs provide manufacturing services to their clients on a contract basis to supply quality products, on time at a competitive price. Upon signing a CMO contract with a client, a complex journey begins to ensure successful manufacturing of biopharmaceuticals. A process called ‘Tech Transfer’ is required to manufacture a molecule that is developed by the client. This involves the transfer of technologies including the manufacturing processes, analysis methods, and testing methods into the CMO partner’s facility. Afterwards, processes called the ‘Engineering Run’ and ‘Process Validation Run’ are conducted to optimize the variables during the manufacturing process, the pilot-scale manufacturing is completed and product’s stability is verified throughout every stage of the process. Only after completing the in-house manufacturing preparation processes can a CMO apply for manufacturing approval of production goods and processes for certification to international regulatory agencies, such as the FDA and the EMA. Once the processes have been approved, large-scale manufacturing can begin. CELL LINE INOCULUM SEED BIOREACTOR PRODUCTION BIOREACTOR HARVEST CHROMATOGRAPHY UF & DF, Bulk Fill Formulation Fill & Finish Procedures of Contract Manufacturing of Biopharmaceuticals Drug products that can be administered to patients are determined only after manufacturing high-quality target proteins in the ‘Cell Culture’ process, extracting only the target antibodies to produce the drug substance (DS) in the ‘Purification’ process. The ‘Aseptic Fill/finish’ process is completed once all of these processes have been conducted. All manufacturing processes strictly abide by the global GMP standards. Samsung Biologics’ Unique Strengths for Contract Manufacturing Services Samsung Biologics currently has the world’s largest biomanufacturing facility in terms of capacity, with the ability to produce up to 364,000 liters at a single site. We have four plants at our site in South Korea. Plant 1 holds an industry standard of 30,000L, and Plants 2 and 3 each offer 154,000L and 180,000L respectively. Upon Plant 4’s completion in 2023, Samsung Biologics will hold a total biomanufacturing capacity of 620,000 liters while offering multi-scale manufacturing services from 1K, 2K, 5K, 10K, and 15K to flexibly respond to all of the clients’ needs at any scale. Plant 1 Cell culture capacity 5K x 6 = 30,000L Plant 1 Capability Liquid & Lyo vials Plant 1 cGMP ready Jun. 2013 Plant 1 Laboratories QC Laboratory Plant 2 Cell culture capacity (1.5K x 10) + (1K x 2 SUS) + (1K x 2 SS) = 154,000L Plant 2 Capability Liquid & Lyo vials Plant 2 cGMP ready Fed. 2013 Plant 2 Laboratories PD Laboratories Plant 3 Cell culture capacity 15K x 12 = 180,000L Plant 3 Capabillity Fed-batch with N-1 perfusion capability Plant 3 cGMP ready Oct. 2018 Plant 3 Laboratories QC Laboratory, PD Laboratories Plant 4 Cell culture capacity (15K x 12) + (10K + 6) + (2K + 8) = 256,000L Plant 4 Capabillity Multi-scale, digitalizations, automation, eco-friendly
research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Samsung Biologics’ CDO business brings quality-driven development services at a greater speed, delivering cell line development to DS manufacturing in six months, and to DP manufacturing in seven months at the fastest pace in the industry. The company is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire global bio-CMO capacity.
researcher in a small Bay Area biotech firm to the quality sector in biopharma was a no-brainer for Sonya Lee. As a Senior Manager in our Quality Center, she finds the most value in her job when she’s working to improve quality processes for the company. At Samsung Biologics, our Quality Control & Assurance teams provide support for the production of high-quality biopharmaceuticals through optimized systems and processes, ultimately to satisfy our clients, meet regulatory requirements, and ensure successful cGMP manufacturing operations. Sonya breaks down why quality and process improvement are so important, and how they make up a core element of the company’s “Driven. For Life.” mission. What are your job responsibilities at Samsung Biologics?I’m responsible for leading two process improvement projects that integrate all of the different cross-functional groups within Samsung Biologics. What does process improvement mean in the biopharmaceutical industry?Process improvement, for me, is an assessment of where we currently are, how our business processes are set up, how our quality processes are set up, and figuring out a way to make both of those better in order to ensure that we can manufacture for our clients with speed and quality. Process improvements in the biopharma sector are very tricky because we have to ensure that we’re building agility into our processes, while maintaining quality for the fact of patient safety. If we have slow, inefficient processes, then our patients are impacted because we can’t manufacture product faster. If we compromise on quality as a result of business process improvement, then now we’re risking patient safety. So one of the big things that I focus on at Samsung Biologics is ensuring we balance those two, faster and better. How does this ultimately impact our clients?Building business processes that are more efficient and have quality impact our clients because by doing so, we’re able to take on more capacity. From an agility perspective, we’re able to manufacture for a more diverse population of clients, and a result, more patients. If we don’t have quality processes in place, then our clients are directly impacted because now, we’re going to be slowed down if we have to investigate those events. How does data integrity and modernizing quality management go hand in hand?In order to build a mature quality system, we need to have mature data integrity integrated into our systems. We can use the data that we’re generating electronically to make predictive analytics and to look at the data proactively instead of reactively, and by doing so we can help support our clients better…Everything we do at Samsung Biologics is really for ensuring that our clients are satisfied. What makes Samsung Biologics’ culture unique?I think one of the unique aspects of Samsung Biologics’ culture is there’s a sense of collective pride across management and employees. Our pride comes from the fact that first of all, we are one of the top companies in the country, and so a lot of people want to work here, and they are proud to work here. The second thing is from the work that we actually do. We manufacture products for patient safety, [and] for patient lives, and so as a result, we’re very proud of the things we do here and it translates in how hard everybody works. What do you like most about working at Samsung Biologics?One of the great things about Samsung Biologics is that we are always striving for better. For example, we just finished building Plant 3 a few years ago, and we achieved number 1 capacity at a single site, but Samsung Biologics wanted to do better so we’ve already broken ground with our new Plant 4. That type of mentality actually translates down all the way through every single employee that we have and it’s one of the great things about working here because you’re always striving for better. When you hear the phrase “Driven. For Life.”, what comes to mind?For me, the phrase “Dri
research firm, the global biopharmaceutical market size is expected to surpass USD 300 billion (approx. KRW 331 trillion) this year. This is more than doubling from USD 151 billion (approx.. KRW 155 trillion) in 2012. As we live in a new era of biotechnology, now more than ever, how we understand diseases and where we seek cures are becoming extremely important. In this article, we will go into detail about what are biomedicines, how they are developed and manufactured, and how they affect people’s lives. Biomedicines are therapeutic drugs that are produced in living organisms in the forms of antibodies, recombinant proteins, and cell and gene therapies. Derived from living organisms, biomedicines have lower toxicity and side effects, and are much higher in efficacy to target specific chronic illnesses such as cancer, autoimmune disease, and Alzheimer’s disease, etc. The most common biomedicine is insulin, which is a hormone that controls the amount of glucose in your bloodstream and plays an important role in regulating the body's metabolic system. A rise in blood sugar levels would lead a typical person’s pancreas to release insulin. However in case of abnormal insulin secretion, a person’s blood sugar level may dangerously rise and cause diabetes, in which case insulin injection would be administered to manually control the blood sugar level. Biomedicines are different to chemically synthesized drugs. Chemically synthetized drugs are commonly known for medications you would take for headaches or indigestion and are generally administered orally. They are relatively smaller in size (molecular weight), simpler in terms of structure, and are less target specific with higher side effects. The principle of immunization through vaccination was the initial mechanism that was employed for the first-ever biomedicine. For many centuries, smallpox devastated mankind. In the 18th century, Edward Jenner, an English physician and scientist, took interest in the protective effects of cowpox. He had found that dairymaids were protected from smallpox naturally after having suffered from cowpox. Based on this, Jenner had concluded that cowpox not only protected people against smallpox, but also that it could be transmitted from one person to another as an intentional mechanism of protection. Through this research, he pioneered the concept of vaccines and demonstrated the first-ever scientific attempt to control an infectious disease through vaccination. In the 19th century, Pasteur developed the overall principle of vaccines and further contributed to the foundation of immunology. He developed the vaccine for anthrax by attenuating the virus in rabbits and subsequently harvesting it from their spinal cords. In the 20th century, he continued to develop vaccines for plague, measles, rubella, varicella, and rotavirus. Biomedicines can be largely classified as vaccines, antibody therapy, cell and gene therapy, and cell therapy. As previously mentioned, vaccines are a biomedicine that produce immunity to a specific disease by deliberately injecting a diluted pathogen into the body to create antibodies that will combat the disease. Antibody therapy is a form of immunotherapy that uses antibodies to monospecifically bind to certain cells or proteins to stimulate the patient’s immune system to attack the cells. Commonly known antibody therapies are Humira (autoimmune disease treatment), Remicade (rheumatoid arthritis treatment), Rituxan (blood cancer treatment), and Herceptin (breast cancer treatment). As a form of protein, antibodies can also be categorized as protein therapies, and are relatively stable i
Research and Development in the US and Europe. John has also held senior leadership roles with Astellas Pharmaceuticals in General Management, Sales & Marketing, Technical Operations, Customer Service, Business Development, and Strategic Planning. John has over 30 years’ experience in the biopharmaceutical industry and began his career as a management consultant with Booz, Allen & Hamilton consulting to pharmaceutical companies in the US and Europe. “I am deeply grateful and excited by the opportunity to lead Samsung Biologics into the next decade,” said John Rim, CEO of Samsung Biologics. “This is an extraordinary company, unparalleled in its phenomenal growth and dedication to client satisfaction, made possible by the company’s unrelenting vision and passion, and business ution by great people whom I will have the privilege to lead as CEO.”Samsung Biologics has shown strong performance throughout the year with a continuous increase in sales volume across all plants, stable business and supply management, and global business expansion including the opening of its first US CDO R&D Center in San Francisco. The company also recently commenced construction of its fourth plant, which is expected to further boost the company’s competitiveness in serving the growing global demand for CDMO scale and flexibility.
INCHEON, S. KOREA and NEW YORK CITY, US, 02 November 2020 – Samsung Biologics Co., Ltd. (“Samsung Biologics”) (KRX: 207940.KS) and Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), today announced the expansion of a long-term manufacturing partnership for Checkpoint’s anti-PD-L1 antibody, cosibelimab. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for Checkpoint. Under the new agreement, Samsung Biologics will commence manufacturing in 2021 in Plant 1. “We look forward to continuing our manufacturing partnership with Samsung Biologics for our lead product candidate, cosibelimab, currently in a pivotal clinical trial for metastatic cutaneous squamous cell carcinoma. Checkpoint is on track to report full topline results from the pivotal trial in mid-2021,” said James F. Oliviero, President and Chief utive Officer of Checkpoint. “This agreement provides Checkpoint access to a top-tier manufacturing site for the long-term commercial supply of cosibelimab after potential regulatory approvals worldwide.” “We are extremely proud of this extended partnership with Checkpoint to support our client and make an impact by helping broader patient populations in need,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “As a reliable contract development and manufacturing organization (“CDMO”) service provider, Samsung Biologics offers the highest quality manufacturing for Checkpoint to assist in its endeavor to bring innovative treatments for patients all around the globe.” Samsung Biologics recently announced it will break ground on its fourth plant within this year to commence manufacturing activities in the latter half of 2022, deliver world-class client satisfaction, and fulfill the needs of the growing biopharmaceutical market. About Cutaneous Squamous Cell Carcinoma Cutaneous squamous cell carcinoma (“CSCC”) is the second most common human cancer in the United States, with an estimated annual incidence of 700,000 cases. While most cases are localized tumors amenable to curative resection, approximately 8% of patients will experience a local recurrence, 5% of patients will develop nodal metastases, and an estimated 2% of patients will die from their disease. Ten-year survival rates are less than 20% for patients with regional lymph-node involvement. For those patients who develop distant metastases, the median survival time is estimated to be less than two years. In addition to being a life-threatening disease, CSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. About Cosibelimab Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (“ADCC”) for potential enhanced efficacy in certain tumor types. About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating
research and development capabilities present at its headquarters in Incheon, South Korea. Samsung Biologics’ CDO business brings quality-driven development services at a greater speed, delivering cell line development to DS manufacturing in six months, and to DP manufacturing in seven months at the fastest pace in the industry. “We’re starting the CDO R&D Center today in San Francisco, and we plan to continue our expansion into Boston, Europe, and China moving forward. In 2020 and beyond, our next decade will be marked by global geographical expansion,” said Tae Han Kim, CEO of Samsung Biologics. “Samsung Biologics will continue to provide biopharmaceutical development and manufacturing services with top-notch capabilities and capacity, so that biotech and pharmaceutical companies can focus on their expertise: the discovery, development, or marketing and sales of novel biologics for patients.” Recognized as a CMO Champion for its excellence in capabilities and reliability, its goal is to become CDO champion by 2025. Since its launch, the Samsung Biologics’ CDO business has been growing at a fast rate, contracting nearly 60 projects within just two years and establishing its proprietary cell-line, S-CHOice, showing improved titers up to two-fold from the industry average and maintaining over 90% cell viability. Leveraging the Company’s operational excellence, Samsung Biologics plans to go above and beyond by offering end-to-end service from the early stages of discovery to the final manufacturing of drug products in a shorter development time. With its experts working “next-door,” the newly opened San Francisco CDO R&D Center will bridge Samsung Biologics with its biotech clients in its first step towards global expansion in providing optimized satisfaction and even greater convenience with faster and better service offerings.
research and training institute in Korea. In response to a surge in biomedicine manufacturing in Korea, 60 billion won ($51.3 million) is set to be invested by 2025 to provide advanced training for professionals and resolve imbalances in staffing. This investment is expected to effectively establish Korea as a major biocluster in Asia.
Research Journal. Through preliminary studies, STCube reported that STM418, which selectively masks glycosylation site N58 on PD-1, potently inhibits PD-1/PD-L1 binding to enhance anti-tumor immunity. Under the development and manufacturing agreement, Samsung Biologics will offer full scope of CDO services from cell line development, process development, non-clinical & clinical material manufacturing, to IND submission for global clinical trials of STM418. “We look forward to getting fast IND approval for our novel PD-1 antibody through this extended partnership with Samsung Biologics, a world-class CDMO," said Hyun-jin Jung, CEO of STCube. "We will commence global clinical trials to prove the enhanced efficacy compared to existing PD-1 antibodies.” Samsung Biologics CDO business has been growing at a tremendous pace since its launch in 2018 with a high number – over 50% – of clients returning for additional business collaboration. STCube, another returning client, had entered into its first CDO partnership with Samsung Biologics in March this year for an immuno-oncology molecule, STT-003. “We are grateful to STCube for this extended partnership and for recognizing our development expertise and our dedication to bringing client products to market faster and better,” said Dr. Tae Han Kim, CEO of Samsung Biologics.
research. From this year, we will test the safety of PMC-402 and initiate phase I clinical trial by 2021 through collaboration with Samsung Biologics,” said Jin-San Yoo, CEO of PharmAbcine. “Offering full range of services in development, manufacturing, and laboratory testing from our state-of-the-art facilities, Samsung Biologics works intimately with our clients to reach IND and market Faster & Better,” said Tae-Han Kim, CEO of Samsung Biologics. He added, “Through partnership with Samsung Biologics, biotech companies can not only benefit from fast timeline and high quality products, but also concentrate on discovery activity, a core aspect of their business.” Samsung Biologics has played a significant role in the global biopharma landscape by establishing a global scale bio-ecosystem for biotech companies. With the announced opening of its US CDO R&D center in San Francisco later this year, Samsung expects to support more clients around the globe with maximum client satisfaction.
research (CRO) services, Samsung Biologics has achieved sizable growth since its foundation in 2011. The company has also been striving to demonstrate greater transparency, expertise, and diversity in structuring its board, which is currently comprised of seasoned professionals in diverse fields, including finance, accounting, law, and biotechnology, to promote greater independence and strengthened governance. The total number of board members was also increased from five to seven; increasing from two to three for inside directors, and from three to four for outside directors. The seasoned group of professionals brings decades of leadership and business experience, and are expected to optimize decision-making in addition to providing strong oversight and governance. Dr. Tae Han Kim, CEO, and John Chongbo Rim, EVP, were elected as inside directors to bring and maintain continued company and industry expertise. Additionally, Eunice Kyonghee Kim, a professor at Ewha Women University Law School, was appointed as an outside director to enhance global compliance and diversity in the board’s decision-making process. As the founding CEO of Samsung Biologics, Dr. Kim has been the driving force behind the company’s fast and stable growth by establishing joint ventures, achieving key business development successes, and forging a strategic agreement with Biogen to jump-start the drug development business in biosimilars. “Samsung’s quality culture and mindset in the engineering, construction, and maintenance of a contaminant-free environment are core strengths gained from the semiconductor wafer manufacturing business, and gave us a unique competitive advantage in accelerating our entry into the biopharmaceutical industry almost ten years ago,” said Dr. Tae Han Kim. “Despite the ever-challenging environment, all of our employees made tremendous efforts and contributed to this important milestone – the organic turnaround and growth in 2020 which signals our commitment to our shareholders as we head into the next decade.” With his reappointment, Dr. Kim will continue his leadership as CEO and inside board member to ensure leadership and business stability based on the founding philosophy and strategic vision he has inculcated over the past ten years at Samsung Biologics. John Rim, newly appointed inside director, is utive Vice President and head of CMO2 Center in charge of Plant 3 business operations. Mr. Rim has over 35 years of experience in global biopharmaceutical and consulting firms. Prior to joining Samsung Biologics, Mr. Rim served more than ten years at the utive level in global biopharmaceutical companies such as Roche and Genentech and brings a broad spectrum of professional knowledge from manufacturing, development, accounting, to sales. Mr. Rim is expected to contribute to enhancing the company’s business competencies. Eunice Kim, newly added outside director, is a professor at Ewha Women University Law School and a member of the Corporate Governance Committee of Korea Corporate Governance Service (KCGS). Ms. Kim is also a qualified US attorney and has worked as a lawyer in the US. She is currently serving as a compliance and internal control specialist leveraging her experience at Hana Financial Group, Citibank Korea, and KB Financial Group as an utive and outside director. Ms. Kim is the first female board member of Samsung Biologics and brings greater compliance expertise and diversity. Additionally, Ms. Kim’s appointment will contribute to strengthening critical elements of the company’s internal control system and efficiently supporting regulated entities and professional activities subject to global compliance within the board. The company also took maximum safety precautions in carrying out the annual meeting in light of the COVID-19 situation. From thoroughly disinfecting the meeting hall and adjacent areas, posting professional medical staff on site, to limiting and distancing attendees whose temperatures were also tak
Research Institute, based on its consumer activity-related big data analyses in multiple categories including Participation index, Communication index, Community index, and Market index. Samsung Biologics was ranked first place in February with a BRI of 8,311,153, followed by Celltrion Healthcare in second, and Chong Kun Dang Pharmaceutical in third. Since the company’s initial listing in 2016, Samsung Biologics has shown steady growth in its performance – revenue and profits have been climbing, debt ratio improved, and the yearly number of contracts signed jumped 30% for CMO and 740% for CDO from 2018 to 2019. Samsung Biologics has also been actively monitoring and communicating operational countermeasures amidst the recent COVID-19 crisis, working to address both client and public concerns.
research centre in Maryland, and has been a subject of a Material Transfer Agreement (MTA) between the firm and an unnamed pharmaceutical company. STCube is planning clinical trials at medical institutions in the US and has said it aims to file an IND for the antibody next year, both as a monotherapy and in combination with other products. CDO businessSTCube said it hired Samsung Biologics based on the rapid growth of the contractor’s development and manufacturing capabilities and solid positioning in the global market. In January Samsung Biologics announced it had seen an increase in development contracts in 2019. The firm also told this publication last year it will open a contract development (CDO) laboratory in the US, and has since said labs in the San Francisco Bay Area set to open next month will be its first expansion outside South Korea. Speaking at the recent JP Morgan healthcare conference vice president John Rim said the CDO lab in the US will place Samsung Biologics closer to potential partners with promising molecules. He also confirmed that, as of end-2019, Samsung Biologics had 35 CMO deals, 47 US’ Food and Drug Administration-approved products developed from its plants, 42 CDO projects and 10 contract research (CRO) projects.
research. STCube decided to establish a strategic partnership with Samsung Biologics based on the rapid growth of the company’s development and manufacturing capabilities and solid positioning in the global market as a world-class CDO. The two companies made an agile move into an agreement as it took only two weeks from the initial stage of discussion to the completion of the contract. STT-003 antibody, developed by STCube’s US based research center located in Maryland, has been a subject of a Material Transfer Agreement (MTA) between STCube and a multinational pharmaceutical company. A novel immune checkpoint STT-003 is found to extensively express over the surfaces of immune and cancer cells, suppressing their immune functions. Partly because of this high ex-pression of STT-003 in various cancer cells, therapies targeting STT-003 are expected to exhibit more favorable anti-cancer effects than conventional PD-1/PD-L1 therapies. STCube is planning to submit an IND on its STT-003 antibody in 2021, both for the use as monotherapy and the use in combination therapy. Clinical trials are currently being planned at leading medical institutions in the U.S. "We have signed a contract with Samsung Biologics, a global CMO, CDO and CRO company, to produce first-in-class STT-003 antibody, laying the foundation for stable implementation of global clinical trials," Hyun-Jin Jung, CEO of STCube said. "So far, several globally recognized immunologists have agreed to serve on the scientific advisory board for phase I clinical studies of STT-003 antibody, including the head of clinical research at a world leading clinical institution for cancer treatment." “We are proud to contribute to the development of this exciting novel target anti-cancer drug candidate through our continued partnership,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “As a world-leading CMO, CDO and CRO partner, we will continue to offer Faster & Better service to our clients for maximum client satisfaction through Samsung’s competitive advantages: faster timeline, excellent quality, and outstanding capability.” About Samsung Biologics Co.,Ltd.Established in 2011 and headquartered in Songdo, South Korea, Samsung Biologics (KRX: 207940.KS) is a world-class CMO, CDO, and CRO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With a flawless regulatory approvals record, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit samsungbiologics.com. About STCube .,Inc.STCube, Inc (KRX: 052020.KQ) headquartered in Seoul, South Korea is an innovative global biopharmaceutical company devoted to developing the next generation of anti-cancer immunotherapy. For more information, visit www.stcube.com
research and development to commercialization. This strategy works only for those with deep enough pockets to build plants, however.Once Samsung Biologics found itself sure-footed, with three plants that meet Good Manufacturing Practice standards, it began to diversify its business portfolio to contract development and contract research in 2017, which are the phases before and after CMO.Still, its core strength is in CMO, where Chinese competition so far is dismissible.Chinese facilities have yet to catch up with GMP compliance, with one of the few exceptions being contract development business WuXi Biologics.But while WuXi can leverage resources and head count for its global deals, the company does not have the stainless steel capability to scale up its production capacity for CMO, Rim said. Its manufacturing output is at batch sizes of 1,000 tons and 2,000 tons through single-use, disposable materials.Samsung Biologics has a single-use facility for clients who seek it, but its competitive advantage is its technological capacity to run its 5,000-ton and 15,000-ton stainless steel bioreactors.When asked if his board member seat at Samsung Bioepis does not conflict with his utive role at Samsung Biologics, Rim said the ultimate focus is Samsung itself.Samsung Bioepis is a biosimilar developer set up by Samsung Biologics in a joint venture with American biotech firm Biogen.“Not the specific areas, specific departments or specific plants, but how do you move Samsung forward. If you have that mindset then it’s easy,” he said.At Samsung Biologics, Rim’s responsibilities include the overall management of CMO 2, which encompasses facility plant No. 3 and subsequent facilities that will be coming, such as plant No. 4 and the contract development organization research lab that’s going to be built in Brisbane, California, within the first half of this year. All rights are reserved by the media that published this article.
research (CRO) projects. Founded in 2011, the biologics arm of Korea’s biggest conglomerate group touts itself as a CMO champion with the world’s largest production capacity of 364,000 liters across its three plants in Songdo, Incheon and Gyeonggi Province. Its goal now is to become the champion in all steps of the value chain of biologics drug-related outsourcing. Since 2017, the firm has been expanding its service areas to CDO, CRO and lately small-scale CMO, to provide a one-stop solution for clients. “The number of biotech companies are increasing dramatically,” CEO Kim said. “Last year, I think there were about 6,000 biotech firms. If you ask me about this year, I’ll say 9,000. Next year, that’s going to be 12,000 or 13,000. And 99 percent of these companies do not have manufacturing facilities,” Kim said. For this reason, they need a competent CDO. “Their short-term demand is not large-scale manufacturing. That’s why they need many 1,000-liter bioreactors. We started to build these small reactors to meet their needs,” Kim said. Samsung Biologics is now offering everything the client needs -- from identifying drug candidates to research and development, regulatory filing, bio-safety tests and commercialization. “Someday we will need to build our own marketing and sales organization, too. It’s not difficult, but it’s a matter of economies of scale. My rule of thumb is that you have to reach $500 million revenue to build a global marketing organization. Before that, we’d like to keep the partnership with Merck and Biogen,” said CEO Kim. Merck oversees marketing and sales of Samsung Biologics-owned biosimilar company Samsung Bioepis. Biogen takes care of the branding in Europe. In Hong Kong and Taiwan, the products are sold by Mundipharma. While revving up the engine to gradually go global, Samsung Biologics said Korea remains an attractive location. “Korea has a competitive edge over other countries in terms of labor costs. The depreciation capital is nearly 50 percent lower than our competitors,” Rim said, indicating that the fourth and fifth plants will also be built in Songdo, close to the company’s headquarters. Samsung Biologics already has secured land for its fourth plant, but will look for land in Songdo for the fifth plant when such expansion becomes necessary. All rights are reserved by the media that published this article.
research and clinical trials. Once these ingredients get the green light for innovative new drug application and biologics license from health care authorities, they can be used on animals for preclinical trials and controlled group of humans. The batch is small at this point, and will become large and money-spinning when it crosses over to CMO deals, which involve commercialization of the drug.“Being involved from the CDO stage allows us to foresee what CMO deals we are likely have in two or three years. With this foresight, we can build our fourth and fifth plants accordingly,” Yang said.Using Samsung BioLogics’ CDO and CMO services is a win-win deal for biotech firms also. When a small company decides to move up from CDO level to CMO level production, changing facilities would require technology transfers which alone can cost a year’s time, he noted.CDO is a tighter race against time than CMO. Which company proves drug efficacy and enters the market first is critical for its business. One or two months make all the difference, Yang said.Aside from having the manufacturing capacity of 364,000 liters in a single generation, Samsung BioLogics is investing heavily in the latest technologies that would give it the necessary leverage to stay on top of the game.It has reduced the number of months that it normally takes to bring a drug candidate from discovery to IND filing, from 18 to 14 months. It takes only 11 months for Samsung Biologics to bring a drug candidate to the state it can be used for clinical phase 1 trials, Yang said, and the company is trying to shorten that further to nine months.Samsung Biologics is also the first from Asia to adopt Berkeley Light Beacon, which enables fully automated live cell isolation, selection and screening in nanopens. Cell line development finishes in three months with the use of Beacon -- earlier just the screening part took two months.Yang said that Samsung Biologics has benefited Korean biotechs over foreign firms so far, when it selects from the myriad business invitations.“Epigyny within the Korean ecosystem has been a crucial mission for Samsung Biologics since 2019,” said Yang, “We currently have 25:75 ratio of foreign and Korean clients for CDO partnerships -- but we will start picking up more global partners from 2021.”Samsung Biologics’ plants 1, 2 and 3 are able to cover advanced molecules, not to mention provide them whatever volume they request.The CDMO currently has 45 CDO partnerships and has helped 47 novel drug approvals of its partnering firms. Innovative biotech firms like GI Innovation, Eutilex and ImmuneOnsia are a few of its partners.GI Innovtion’s innovative drug designs were the toughest to produce -- but Samsung Biologics was able to deliver what was asked: monoclonal antibody, fusion protein and bispecific fusion protein, among many others.GI Innovation CEO Nam Su-youn said that having Samsung Biologics as the manufacturer and supplier of the company’s innovative drugs was a favorable factor in its solid tumor pipeline licensing deal with Nanjing Simcere Dongyuan Pharmaceutical in November, worth 900 billion won ($779 million).“Not only was Samsung Biologics able to identify the best cell line out of thousands, it was also proactively helpful in answering our inquiries,” Nam said, “Simcere officials visited Samsung Biologics’ plants many times during the business discussions. Having Samsung Biologics as the manufacturer reduced the business risks.”Nam and company co-founder Jang Myoung-ho are in San Francisco for the JP Morgan Healthcare Conference to hold business meetings with global big pharmas for developing combination cancer treatment with its cold tumor treatment pipeline GI-101 and its allergy treatment pipeline GI-301.Half of what Samsung Biologics three plants churn out now are antibody; the other half being specific antibody therapies. The company is yet to see economies of scale for gene and cell therapies but said it is keenly watching the global rese
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.
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
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.”
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.
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 ?
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 ?
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”.
research firm "EvaluatePharma" estimates the annual growth rate of the biopharmaceutical market will be 9.5% for the next 5 years. Amidst these market trends, global pharmaceutical companies are expected to focus internal resources on R&D and marketing while outsourcing 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
research conducted with Industry Standard Research (ISR). More than 80 contract
manufacturers around the world were assessed by 30 performance metrics in ISR’s
annual Contract Manufacturing Quality Benchmarking survey to determine winners
in the six categories. The survey questioned those from pharmaceutical and biopharmaceutical
companies of all sizes and were screened for decision-making related to working
with contract manufacturing suppliers. They were asked questions about their
perception of suppliers.
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.
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.
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Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
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