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Quratis

Tel : +82 70 4141 5942   Fax : +82 2 867 0125   Email : info@quratis.com

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BUSINESS

CMO&CDMO

(Clinical trial) GMP Biomanufacturing

→ Recombinant DNA based cGMP Biomanufacturing Facility and Wide Work Experience

  • cGMP Compliant Manufacturing Facility for (clinical trial) Biologics
  • 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 DNA based Biologics Development 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 (Recombinant protein, DNA and mRNA)
  • 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

→ Analytical Method Development and Support

  • Analytical Method Development suitable for Each Product Characteristics(Identity, Quantity, Purity, Potency, Impurities, Endotoxin, Physico-chemical tests)
  • Analytical Method Validation (Specificity, Accuracy, Precision, Detection Limit, Quantitation, Limit, Linearity, Range, Robustness)
  • Stability tests

→ Validation

  • To carry on Procedure on Validation and Qualification Guideline

Validation

  • Process Validatoin, 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 Acceptanc Test, SAT
  • Installation Qualification, IQ
  • Operational Qualification, QQ
  • Performance Qualification, PQ
  • 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 m2

→ Construction Schedule

  • August of 2020. completion

→ 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