SERACH RESULTS FOR" Development "
Drug ProductDevelopmentSamsung BioLogics provides Formulation services for Drug Product Fill and Finish. Formulations can be completed from both single use systems or hard pipe systems. Additionally, we provide optimized type formulations while securing stability and effectiveness for the customer within the time they need. We are also fulfilling customer satisfaction through development service that considers even the permitted articles following the relevant formulations. Core EquipmentSmall scale lyoDown Flow BoothDSCKarl FisherFreeze Dryer MicroscopeManual Filler (Peristaltic Type)Specialized CapabilityBiopharmaceuticalsMonoclonal antibodiesFusion proteinsBispecific antibodiesPackaging (Vials)ProteinsPeptidesFormulation process optimization based on QbDFormulation DevelopmentFormulation DevelopmentThawEquipmentFreeze/Thaw skid for cryovesselsFreeze/Thaw skid for cryobagsCapacity/CapabilityControlled freezing and thawingMax. capacity : 1 tank per stationTemperature range : -70ºC to 40ºCThawThawFormulationPlant 1EquipmentExcipient and formulation vesselsCapacity/CapabilityExcipient vessel capacity : 20L to 3,000LFormulation vessel capacity : 20L to 1,500LpH and temperature controlWeight controlCIP/SIP of excipient and formulation vesselsSingle use solutions capabilitiesPlant 2EquipmentExcipient and formulation vesselsCapacity/CapabilityExcipient vessel capacity : 200L to 2,000LFormulation vessel capacity : 200L to 2,500LpH and temperature controlWeight controlCIP/SIP of excipient and formulation vesselsSingle use solutions capabilitiesVial Preparation and FillingPlant 1EquipmentWashing, depyrogenation, vial fillingStoppering, capping, transfer to lyoCapacity/CapabilityActive RABSFilling rate : up to 12,000 vials/hrFilling operation range : 0.1 ~ 100mlPump types : piston and peristalticCIP/SIP of vial filling machine2mL to 50mL vial sizeGRADE A over sealingAdaptable process to include single use or fixed systemsInline IPC capability (non-destructive testing)Plant 2EquipmentWashing, depyrogenation, vial fillingStoppering, cappingCapacity/CapabilityActive RABS, Piston & Peristatic PumpMax. capacity : 300 vials/min (based on 10ml vial)Filling operation range : 0.1ml to 100ml100% weight check systemCIP/SIP of vial filling machineGRADE A over sealing (enclosed RABS)Adaptable process to include single use or fixed systemsVial Preparation and FillingVial Preparation and FillingInspectionManual InspectionEquipmentManual inspection BoothsCapacity/CapabilityComprehensive visual inspection programOperators' manual inspection qualificationProduct type : liquid, high viscosity, and lyophilizedDefect classification library and qualification programs developed for all product typesVial cap printing capabilities availableSemi Automatic and Automated InspectionEquipmentAutomated inspection lineCapacity/CapabilityLine speed : 12,000 vials/hr (20R vial)Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc.InspectionInspectionPackagingEquipmentManual bulk packagingCapacity/CapabilityLine speed : 18,000 vials/hr (30mm diameter vial)Pakaging type : labeler, cartoner, overwrapperLaser carton print systemAutomatic weight check unit between cartoner and overwrapperPackagingLYOPHILIZATIONEquipmentTwo(2) lyophilizersCapacity/CapabilityMax. loading capacity : 32,000 vials (10ml) per lyoIce load capacity : 300kgShelf area : 16.7 ㎡Automatic loading and unloading system with RABSLyophilizationLyophilizationLyophilization Cycle Development and Commercial ScalabilityLyophilized product design Product characterization Thermal characterization of product (Tg, Tg’, Teu,Tc)Characterization of freezing step (crystalline or amorphous)Finished product analysis specific to lyophilized products Karl Fisher moisturePhysical appearanceAttributes of constituted solution (time, clarity, PM)Lyophilized formulation development support Manufacturing of small-scale batches for development stability Troubleshooting commercial
Drug SubstanceDevelopment StagecGMP clinical & commercial cGMP clinical & commercial Plant SpecificationsShaker or Magnetic Stirring Flask CultureHybrid Depth Filtration System (POD, Typical Lenticular)Cultivation Type: Fed-BatchCentrifuge Shaker or Magnetic Stirring Flask CultureHybrid Depth Filtration System (POD, Typical Lenticular)Cultivation Type: Fed-Batch, Perfusion GMP OperationalQ3 2017 Q2 2020 (planned) Regulatory ComplianceGlobal HA including FDA, EMA, PMDA, MFDS, Health Canada Purification Specifications items include CMO 1 CMO 1 TypeDS 1 DS 2 Total Capacity30,000L 150,000L Production Scale5,000L (x 6)Three Trains 15,000L (x 10)Five Trains Bioreactor TypeStainless Steel Stainless Steel Development StagecGMP late clinical & commercial cGMP late clinical & commercial Plant SpecificationsShaker or Magnetic Stirring Flask CultureHybrid Depth Filtration System (POD, Typical Lenticular)Cultivation Type: Fed-BatchCentrifuge Shaker or Magnetic Stirring Flask CultureLenticular Depth Filtration SystemCultivation Type: Fed-BatchCentrifuge GMP OperationalQ3 2013 Q1 2016 Regulatory ComplianceGlobal HA including FDA, EMA, PMDA, MFDS, Health Canada Purification Specifications items include CMO 2 CMO 2 TypeDS 3 Total Capacity180,000L Production Scale15,000L (x 12)Six TrainsTwo DSP Trains Bioreactor TypeStainless Steel Development StagecGMP late clinical & commercial Plant SpecificationsShaker or Magnetic Stirring Flask CultureLenticular Depth Filtration SystemCultivation Type: Fed-Batch, PerfusionCentrifuge GMP OperationalQ4 2018 RegulatoryComplianceGlobal HA including FDA, EMA, PMDA, MFDS, Health Canada Equipment/Capability Equipment/CapabilityStart TourEquipment/CapabilityEquipment/Capability Equipment/CapabilityEquipment/CapabilityEquipment/CapabilityEquipment/Capability pause PurificationMaximum Flexibility & Minimum Turnover TimeSamsung 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 SolutionsEach 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.SpecificationFacility 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 Columns to accommodate all range of sizesDedicated equipment for Pre-Viral and Post-Viral areas for cross-contamination control COP and glassware parts washers Autoclaves Utility station with CIP and SIP capabilities for portable equipment CIP and SIP capabilities for all production equipmentVF Operation : Fully automated Hybrid design to accommodate any configurationUFDF Operation : Fully automatedIn line and off line Recirc vessel ca
ResearchDEVELOPMENT 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 / De ionBio-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
DevelopmentDevelopment Faster & BetterYOUR SUCCESS TO IND & BLA As your most qualified world’s leading CDMO partner, Samsung BioLogics delivers your success to IND & BLA Faster & Better with maximum flexibility. We promise the Best. From Gene to INDFrom Gene to IND1. Cell Line Development2. MCB Banking and Characterization3.Upstream Process DevelopmentDownstream Process DevelopmentFormulation DevelopmentAnalytical Method Development4.Non-GMP DS & DP ProdcutionDS & DP IND Stability (Tox. lot)5.cGMP DS ManufacturingcGMP 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 CMP Facilities 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’ d
QUALITY CONTROLDevelopment / 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.
Our Servicesdevelopment to commercial manufacturing 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 2015 FDA: 1│EMA: 0 │ PMDA: 0 │ OTHERS: 0 │ SUM: 12016 FDA: 3│EMA: 4 │ PMDA: 0 │ OTHERS: 0 │ SUM: 72017 FDA: 4│EMA: 5 │ PMDA: 2 │ OTHERS: 1 │ SUM: 122018 FDA: 8│EMA: 7 │ PMDA: 2 │ OTHERS: 6 │ SUM: 232019 FDA: 8│EMA: 11 │ PMDA: 3 │ OTHERS: 20 │SUM: 42 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.