SERACH RESULTS FOR" Manufacturing "
ManufacturingManufacturing A CDMO Beyond Measure DRUG SUBSTANCE Samsung BioLogics offers advanced cGMP facilities providing clinical and commercial products based on mammalian cell culture. All processes are cGMP-compliant and meet the regulations of U.S. FDA, EMA, and local authorities. Samsung BioLogics' dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production. CELL CULTURE Safe & Reliable Process Our versatile Bioreactors, Media Prep Vessels (HTST available), Centrifugation, Depth Filtration, and CIP Systems are designed for minimizing cross-contamination. Specification Facility design based on gravity flowPlant dedicated utility committed to providing constant power supplySeparate Flask Culture Suites (Made for Specific Products) Grade B environment with Grade A operational areasBioreactors : Fed-Batch, Perfusion (N-1 Step, Plant 3), Various Addition Lines, Wide range of Sparging, Single use/Stainless Steel bioreactor at N-4 stepMedia Preparation : Various sizes of media prep vessels, HTST (High Temperature Short Time) Capability, Segregated Special Media Prep AreaHarvest : Capability of Large Depth Filtration Areas, Centrifugation Processing, and controls for Harvest Pool Vessels Equipment/Capability division Plant 1 Plant 2 CMP Plant 3Type Mammalian Mammalian Mammalian MammalianTotal Capacity 30,000 L 150,000 L 2,000 L 180,000 LProduction Scale 5,000L (x 6) Three Trains 15,000L (x 10) Five Trains 1,000L (x 2) 15,000L (x 12) Six TrainsBioreactor Type Stainless Steel Stainless Steel Stainless Steel Stainless SteelDevelopment Stage cGMP late clinical & commercial cGMP late clinical & commercial cGMP clinical cGMP late clinical & commercialPlant Specifications Shaker or Magnetic Stirring Flask CultureHybrid Depth Filtration System (POD, Typical Lenticular)Cultivation Type: Fed-BatchShaker or Magnetic Stirring Flask CultureLenticular Depth Filtration SystemCultivation Type: Fed-Batch- Shaker or Magnetic Stirring Flask CultureLenticular Depth Filtration SystemCultivation Type: Fed-Batch, PerfusionOperational Q3 2013 Q1 2016 2H 2016 Q4 2018Regulatory Compliance Global HA including FDA, EMA, PMDA, MFDS, Health Canada PURIFICATION Maximum Flexibility & Minimum Turnover Time Samsung BioLogics’ cGMP Drug Substance Downstream Purification consists of two facilities with the newest equipment for cGMP operations, including chromatography (e.g., affinity, ion-exchange, multi-modal), viral filtration, ultrafiltration/diafiltration (UF/DF), and formulation and bulk filling operations. Both facilities consist of physically segregated pre-viral and post-viral suites designed for maximum flexibility and minimum turnover time. Industry Leading Automation Solutions Each downstream facility can be adjusted to accommodate all customer process needs. All purification facilities are classified as Grade C or higher. The design minimizes opportunities for cross-contamination with physically segregated pre-viral and post-viral suites containing equipment dedicated to cleaning areas and a Grade B bulk fill room. Three separate column packing suites support optimization of production cadence. The high-capacity buffer preparation suites are designed for temperature control and contain hold tank sizes to handle buffer preparations up to 15,000 L. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A (laminar flow booth) bulk filling capacity as well as product pool vessel capacities from 200 L to 15,000 L to handle a wide range of pool volumes and high protein titers. Our purification process is supported by industry leading automation solutions. Specification Facility design based on gravity flowPlant dedicated utility committed to providing constant power supplyChromatography : Affinity, Ion Exchange, Hydrophobic, Multi-modal Columns range : 0.8m to 1.8m in diameter Automation controls integrated with MCS Column
DevelopmentManufacturingcGMP DS Stability Study6.cGMP DP ManufacturingcGMP DP Stability Study7. IND Filing Support Timeline – Speed to IND Timeline of Cell Line development to DS productionYear Month Construction CLD to IND Filing : ~ 18 MonthCLD to DS Production : ~ 12 Month DS to IND Filing Semi-fast -2M Vector Construction -1M Year 1 1M Cell Line Development 2M 3M 4M Process Development- Upstream- Downstream- Formulation- Anaytical Method 5M 6M Non GMP DS (Tox.)- Non GMP DS Stability- Non GMP DP Stability- Interim Reference Stadard Qualification 7M 8M Analytical Method Transfer to QC 9M 10M Virus Clearance Study 11M cGMP Clinical DS- Lot Release- cGMP DS Stability 12M Year 2 13M GMP DS Characterization 14M 15M cGMP DP- Lot Release- cGMP DS Stability Regulatory Documentation16M 17M 18M CELL LINE DEVELOPMENT Right Start, and Better Quality At Samsung BioLogics, we provide high-quality mammalian cell line development for a variety of antibodies and proteins using the CHOZN platform. Along with Samsung BioLogics’ specialized cell line development know-how, our experts have extensive experience of molecule development including difficult-to-handle products and are capable of delivering robust, high-yield single cell clone to our clients. Cell Line Development Platform Process 1,2 : 1st screeing - Screen and rank potential clones into 5 pools3 : Single Cell Cloning - Support monoclonial process4 : 2nd screening - Screen and rank of top 10 subclones6 : Top 3 RCB - Screen and rank of top 10 subclones6 : Stability Study - Assess stable maintanance of titer and product qualtiy6.5 : Fed-Batch - Assess stable maintanance of titer and product qualtiy UPSTREAM PROCESS DEVELOPMENT Samsung BioLogics has a highly skillful development R&D team with dedicated focus on advanced development services. With our sophisticated platform development process, our team provides Process Development services utilizing Quality by Design (QbD) approach. Upstream Process Development Flow Molecule information / cell bank transferBasal Media Screening in shake flaskFeed Media Screening in shake flaskProcess Optimization In Ambr 15™Process verification run in 2L STR DOWNSTREAM PROCESS DEVELOPMENT Samsung BioLogics offers our established downstream process development platform developed by our highly experienced scientists. Together with our insights in bioprocess and manufacturing, we are capable of developing a customized, optimal and efficient process resulting in high yield manufacture in a timely manner. Downstream Process Development Flow Preparation for DSP Development Virus Inactivation Process Development Filter Preocess Development Process verification run in AKRA ANALYTICAL METHOD DEVELOPMENT Analytical Method Development Analytical Method Development - Quantity- Impurities- Identity- Potency- Glycan profile- Excipient- Purity & Heterogeneity Extended characterization & comparability studies - Primary strucure- High order structure- Biological activity Analytical Support - In-process analysis for USP and DSP development MANUFACTURING Small Scale Manufacturing – CMP 1 & CMP 2 As the world’s largest CDMO, we offer multiple cGMP manufacturing facilities to meet the diverse scales of our clients’ demands. The CMP Facility has the same best-in-class characteristics and equipment as our large-scale capacity. CMP1-STAINLESS STEEL BIOREACTORS Flask CultureBrx 1x20(N-1) - 20L (nominal volume) wave bioreactorBrx 1x30(N-1) - 40L (w.v) seed bioreactorBrx 1x40(N-1) - 200L (w.v) seed bioreactorBrx 1xY0(N) - 1,000L (w.v) production bioreactor CMP2-SINGLE-USE BIOREACTORS Flask Culture20L - (nominal volume) Single use bioreactor50L (w.v) - seed bioreactor200L (w.v) - seed bioreactor1,000L (w.v) - productio
QUALITY CONTROLManufacturing, Quality & Compliance, and Analytical Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes. Analytical Testing Capabilities Across the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release as well as stability. Our QC team is capable of performing analytical test method transfers from client laboratories and performing the required method validation, qualification, or verification, according to the ICH Q2 (R1) guidelines in order to satisfy the requirements of the U.S. FDA, EMA, and PMDA. Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of: ChemicalTesting 1. pH, Osmolality, Protein Content (A280), Appearance2. Water content3. Identification by FT-IR4. Impurity / Purity by HPLC BiochemicalTesting 1. Enzyme-Linked Immunosorbent Assay (ELISA)2. Polymerase Chain Reaction (PCR)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based Assays MicrobiologicalTesting 1. Microbial Limit (Bioburden)2. Endotoxin3. Microbial Identification4. Sterility Stability Program Capabilities We maintain a controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and the accelerated conditions of temperature and/or light. Environmental and Clean Utility Monitoring Through our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that the controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable particulates, Settle Plates, and Contact Plates. Clean Utilities Monitoring includes the testing for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.
MANUFACTURING FACILITIESMANUFACTURING FACILITIES The world’s largest state-of-the-art facilities, which include bioreactors that can handle production on a small to large scales, and an innovative operating system that can address the diverse needs of our customers across the globe. PLANT 3(2015 ~ 2019) “Largest Single Plant in the World”We fully expect Plant 3 to become the largest plant in the world in terms of scale, ably supported by competitive costs and an aggressive construction schedule. Additionally, the pant is combined with the latest N-1 Perfusion technology to increase the overall efficacy of the production cycle. Total Capacity: 180,000L (12×15KL)Construction : 35 months to cGMP readyManufacturing started in Oct 2018 PLANT 2(2013 ~ 2016) “Record Breaking Performance”Plant 2 is the pinnacle of Samsung’s forty years of engineering and construction expertise, which are fully integrated with our dedicated workforce that have an uncompromising attitude towards achieving excellence and overcoming ever more difficult challenges. Total Capacity: 152,000L (10×15KL / 2×1KL)Construction : 29 months to cGMP readyManufacturing started in 2016 Take 360º Virtual Tour PLANT 1(2011 ~ 2013) “Industry Standard”This pilot project became the focal point of Samsung Group’s talents and experience, as we leveraged our semiconductor design and manufacturing knowledge, EPC project management expertise, and construction capabilities. Total Capacity : 30,000L (6×5KL)Construction : 25 months to cGMP readyManufacturing started in 2013 Concurrent Process for Validation We innovatively build plants using Samsung’s concurrent processing technologies, which allow us to save 40% of the construction lead time, as compared to the traditional approach of engineering and construction management. 29 monthsSamsung BioLogics - 29 months 48 months+ 19 monthsTraditional Approach - 48 months(+19 months) Engineering, Plant Construction, and Validation (EPCV) Expertisze Concurrent processing and maximization of plant operationCombined technologies and multi-industry experience: semiconductors, building and construction, engineering and chemicalsParallel ution of design, procurement, construction, and facility validation activities Technologies & Capabilities in Plant Design Capabilities and know-how in 3D modeling and pipe welding which reduces construction and design errorsThoughtful plant design and expertise with piping are critical to a successful construction of a sophisticated biopharma manufacturing plantConstruction know-how in building construction and sophisticated facilities including semiconductorsIndustry leading team of engineering experts and excellence in construction timeline management Advantages of Expedited Construction Lead Times Samsung BioLogicsFaster response to market demandReduction in construction costsShorter lead time to production ClientsFlexibility in accommodating development and production timeline requirementsShorter products time to market and larger market share capture
Our Servicesmanufacturing of drug substance and product, to biosafety testing services, all from a single location. 01Development Services From cell line development to IND filing support 02ManufacturingServicescGMP DS andDP manufacturing 03Research 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 ution 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.
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.