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Business

CMO & CDMO

Contract Development and Manufacturing Organization

(Clinical trial) GMP Biomanufacturing
    → Recombinant DNA based cGMP Biomanufacturing Facility and Wide Work Experience
  • ∙ cGMP Compliant Manufacturing Facility for (clinical trial) Biologics (Expected to be certified in 2020)
  • ∙ Developing Reproducible Manufacturing Process from Small Scale to Commercial Scale
  • ∙ cGMP Manufacturing and Process Technology for (clinical trial) Biologics based on Microbial Fermentation
  • ∙ cGMP Manufacturing and Process Technology for Parenterals(Liquid, Freeze-dry)
  • ∙ QA Experts Experienced with Various Inspections from Domestic and Overseas Regulatory Authority
  • ∙ Quality Program (Quality system, Facilities & Equipment, Materials, Productions, Packaging & Labeling, Laboratory control) covers cGMP, EU-GMP, KGMP and ICH guidelines
  • ∙ Well Defined Manufacturing Environment: Grade A/B (Sterile filling and supporting area), Grade C/D (microbial control zone), CNC (Controlled not classified)

∙ Recombinant DDA based Biologics Develop Process

∙ GMP manufacturing and validation service for Drug Substance and Drug Product of (clinical trial) Biologics using recombinant DNA technology

Non-GMP manufacturing for non-clinical trial
    → To provide R&D and non-clinical trial drug production service from early stage development for DS and DP of microbial fermentation based recombinant biologics
  • ∙ Fermentation and Purification Process for Recombination (E.coli) Cell Line
  • ∙ Liquid Injection and Freeze-Drying Injection
  • ∙ Analytical Method Development (Identity, Quantity, Potency, Impurities)
Customized Services
    → Customized Services including Manufacturing Process Development of biologics DS and DP
  • ∙ Cell Line Screening for Recombinant DNA Biopharmaceuticals
  • ∙ Development of Fermentation and Purification Condition Satisfied with Customer’s Requirements
  • ∙ Optimization of Fermentation and Purification Process for Drug Substance
  • ∙ Specialized to Validation and Regulatory Affairs Services
    → Fermentation process development
  • ∙ Development and Improvement of Fermentation Condition
  • ∙ Fermentation Process Development: Batch, Fed-batch, Seed Culture
  • ∙ Basal Media and Feeding Media Screening
  • ∙ Fermentation Process Optimization(Study regarding Process Parameters such as Feeding Strategy, Temperature, pH, Initial Cell Density, etc.)
  • ∙ Setup for 50 L and 500 L Fermentation Process
    → Purification Process Development
  • ∙ Process Improvement and Optimization
  • ∙ Purification Process Development
  • ∙ Type & Sizing test for UF/DF Membrane
  • ∙ Setup for Purification Process
    → Scale-up Study
  • ∙ 50 L/500 L Volume Process Setup and Analysis
  • ∙ Technical Transfer of Manufacturing for (Non-) Clinical trial
    → Formulation Development
  • ∙ Optimization on Product and Stability through Formulation Development for Protein and Excipients
  • ∙ Formulation Development for Liquid Injection and Freeze-Drying Injection
    → Physico-chemical tests
  • ∙ Identity, Quantity, Purity, Potency, Impurities, Endotoxin, Physico-chemical tests
  • ∙ Specificity, Accuracy, Precision, Detection Limit, Quantitation, Limit, Linearity, Range, Robustness
  • ∙ stability test
    → Validation
  • ∙ Validation/Qualification
    ∙ Validation
  • - Process Validation, PV
  • - Cleaning Validation, CV
  • - Computer System Validation, CSV
    ∙Qualification
  • - System Impact Assessment, SIA
  • - Risk Assessment, RA
  • - User Requirements Specification, URS
  • - Design Qualification, DQ
  • - Factory Acceptance Test, FAT
  • - Site Acceptance Test, SAT
  • - Installation Qualification, IQ
  • - Operational Qualification, OQ
  • - Performance Qualification, PQ
    Qualification
  • - Qualification Planning
  • - Process Equipment and Utilities
  • - Water Generation and Distribution System):Purified Water, Water For Injection, Clean Steam
  • - HVAC System
  • - Compressed Air System
  • - Clean Room
  • - Computer and Automation System
GMP plant (Osong district bio-plant)
    → Site Area
  • ∙ 19,932 ㎡
    → Construction Schedule
  • ∙ July of 2020 - completion expected
    → GMP Manufacturing Facility
  • ∙ Raw and Packaging material storage (Including Sampling room, Weighing room)
  • ∙ Drug product storage (Coldroom)
  • ∙ Drug substance line (for microorganism fermentation & purification)
  • ∙ Drug product line (for sterile injection & freeze-drying injection)
  • ∙ Packing room (Auto inspection machine, Labelling machine, Packaging line)
  • ∙ QC Lab (Weighing room, Physicochemical lab, Microbiogical lab, Stability/Retention sample room))
  • ∙ Machine room (Pharmaceutical water generation/distribution system, HVAC system, Compressed air system)
    → Utilization Plan
  • ∙ Non-clinical and Clinical Samples of new development items
  • ∙ Commercial products manufacturing
  • ∙ C(D)MO business
    → GMP Target
  • ∙ Compliant with cGMP, EU EMA, KGMP and Other Global Agencies