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safetyHealthEnvironmentManagementSHE Management SAFETY ∙ HEALTH ∙ ENVIRONMENT Samsung BioLogics seeks to realize the harmonious coexistence of individuals, companies, and the environment, and become the World SHE (Safety, Health, and Environment) Champion through operating the strictest Safety, Health, and Environmental management and practices. SHE PolicySafetyHealthEnvironment SHE Policy Samsung BioLogics shall continuously strive to accomplish a no disease, no pollution, and accident-free work environment based upon our principles of complete respect for human life and dignity. Senior management shall remain fully committed to valuing and prioritizing our goals for Safety Health and Environment. (hereinafter called SHE). Senior management shall pay particular attention to the requirements from local communities, governments, and NGOs. All of our employees are expected to actively participate in the daily SHE activities, and each and every employee shall act as an agent of change in creating a better workplace. Samsung BioLogics shall identify all hazardous aspects on employees and minimize any adverse impact. Manufacturing operations shall be in compliance with the legal requirements of Safety, Health, and Environment. All domestic legal requirements shall be satisfied while the international rules and regulations shall be adhered to, as applicable. CEO President,Dr. Tae Han Kim Safety Preventing Accidents Continuous Improvement in the Safety Management System (PDCA) Process Risk AssessmentWe prevent accidents such as fire, explosion, and leaks by managing potential hazards and operational problems that are analyzed regularly based on the risks of the process. Management Work RiskWe carry out voluntary preliminary inspections and safety management systems through work permit systems for dangerous work by analyzing the risk of each work situation. Work MonitoringWe consistently monitor our business sites to keep them safe by constantly checking and improving the production sites and laboratories. Annual Safety Evaluation of Each DepartmentWe practice evaluation systems for the continuous improvement by comprehensively reviewing the safety management status of each division in terms of safety, hygiene, environment, and chemical substances periodically. Identification of Potential RiskIdentification of Potential RiskWe have established a health and safety culture in the organization for which all of our employees participate by taking the appropriate measures of reporting and identifying any potential risks, analyzing the causes and establishing the measures to prevent a recurrence. Emergency Response DrillWe have established various scenarios and conduct annual emergency response training in order to efficiently and systematically respond to the emergency circumstances of human and material resources. Safety Culture Annual Assessment of the Safety Culture (Assessment → Analysis → SHE Annual Plan) Emphasis on Safety Culture from the managementAll our employees strive to strengthen and cultivate a health and safety culture along with the continuous care and support of the management. Safety Awareness TrainingWe annually conduct and analyze safety culture evaluations, and associate the measures of vulnerabilities found with attitude enhancement training to share with all employees. Safety CampaignWe confirm that all employees are aware of the importance of contributing to a health and safety culture by not only implementing legal issues but also organizing a safety campaign on traffic and public security to establish a better safety culture. Safety CommunicationWe are strengthening our organizational communication by exchanging large and small safety issues through monthly health and safety meetings, safety talks & TBM. Safety ChampionWe motivate our employees to display a keen interest in safety issues by selecting a Safety Champion. The Safety Champion is selected across the departments, and these individuals who have achieved excellent safety standards wi
ResearchResearch FORMULATION DEVELOPMENT Effective ProcessSamsung BioLogics develops both liquid and lyophilized drug products. We have an efficient platform process of formulation development based on Design of Experiment (DoE) approach, followed by stability test in long-term, accelerated and stressed conditions. This systematic platform process can help to save development time to IND. Formulation Development Liquid Formulation- Basic buffer & Excipient screening- DoE based Pre-formulation optimization- Nominal / Accelerated pre-stability test- Product impactassessment Lyophilization Development- Characterization of the freezing step- Lyophilized formulation development- Lyophilization cycle optimization- Manufacture of small scale batches Non-GMP Manual Filling- Aseptic manual filling for pre-clinical study- 2R-20R with flip-off al-cap crimping- Watson Marlow PF7 filling machine Other Activities1. Lyophilization Development- Characterization of the freezing step- Lyophilized formulation development- Lyophilization cycle optimization- Manufacture of small scale batches2. Non-GMP Manual Filling- Aseptic manual filling for pre-clinical study· 2R~20R with flip-off al-cap crimping· Watson marlow PF7 filling machine Equipment Capacity / DescriptionBio-safety Cabinet Formulation and other experiments preparationIncubator Stability storage during formulation screening (25C and 40C)Spectrophotometer Protein / DNA concentration analysisCentrifuge General analysisMicro-centrifuge General analysisDSC (MicroCal) Formulation stability simulationDLS (ZetaSizer) Confirm particle size distributionMFI Confirmation of aggregation in DS & DPLiquid Particle Counter (HIAC) Sub-visible particle measurementHPLC Target molecule identification (SEC, CEX, AEX) CRO SERVICESWe provide full CRO service including Contract QC (Release & Stability Testings) to support our client’s successful product launch in Korea BTS : Bio-safety Testing Service Mycoplasma Detection Testing- EP and USP Mycoplasma Culture Method Detection- JP Mycoplasma Culture Method Detection- EP Mycoplasma DNA Detection by PCR* Types of Mycoplasma : Mycoplasma hyorhinis, M. orale, M. fernentans, M.pnuemoniae, M. gallisepticum, Acholeplasma laidlawii Adventitious Virus Testing- In Vitro Assay for MRC-5, Vero and CHO-K1- In Vitro Co-culture / PG S+L- Focus Assay- Specific Virus DNA Limit Detection by qPCR* Types of Virus : Measeles virus, Parainfluenza virus 3, Parainfluenza virus 5, Munute virus of mice (MVM) Microbial Testing- Sterility Testing- Endotoxin Detection / LAL Test- Bioburden- Microbial identification Contract QC Service General Characteristics- Apperarance- Osmolality- pH- Sub-visible particles Chemical- A280- Peptide mapping- HPLC- N-glycan profiling Biological- Cell-based potency- ADCC- Antibody Proliferation Assay Biochemical- SDS-PAGE- iCIEF- DNA qPCR- CE- HCP ELISA
Our ServicesResearch ServicesStand alone contract QC service WORLD CLASS FACILITIES World Class State-of-the-Art Facilities The world’s largest state-of-the-art facilities, which include bioreactors that can handle production at small to large scales, and an innovative operating system that can address the diverse needs of our customers across the globe. Plant 1 Industry Standard / Total Capacity : 30,000L (6 X 5KL) Plant 2 Record Breaking Performance / Total Capacity : 152,000L (10X15KL / 2X1KL) Plant 3 Largest Single Plant in the World / Total Capacity : 180,000L (12X15KL) Take a Tour of Our Facilities 360º VIRTUAL TOUR Take our 360º Virtual Tour for a closer look at the Samsung BioLogics facilities. Please click the button below To take a tour of our facilities Take 360º Virtual Tour THE VERY BEST QUALITY CHOSEN BY CLIENTS Received the “CMO Leadership Award” in all six categories for three consecutive years. By consistently delivering superior client satisfaction through the execution of excellence and innovation, we have received the “CMO Leadership Award” in all six categories for three consecutive years. CMO LEADERSHIP AWARDS 2019 COMPATIBILITYCMO LEADERSHIP AWARDS 2019 EXPERTISECMO LEADERSHIP AWARDS 2019 QUALITYCMO LEADERSHIP AWARDS 2019 RELIABILITYCMO LEADERSHIP AWARDS 2019 SERVICECMO LEADERSHIP AWARDS 2019 CAPABILITIES Quality Operation Proven by Global Approvals FDA EUROPEAN MEDICINES AGENCY PMDA OTHERS SUM2015 1 - - - 12016 3 4 - - 72017 4 5 2 1 122018 8 7 2 3 202019 8 8 3 10 29 QUALITY & COMPLIANCE By continuously improving our quality management system, we strive to rigorously comply with all cGMP international regulations. QUALITY CONTROL Our highly trained quality control team conducts all testing according to guidelines that satisfy the requirements of the FDA, EMA, and PMDA for all production processes with state of the art instruments and systems.
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.
CytoDyn and Samsung BioLogics Formalize 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
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 firstname.lastname@example.org
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.