CN
Services
  • Mammalian cell culture platform
  • Microbial fermentation platform
  • Gene therapy（AAV）
Sequence Confirmation
Cell line/Strain development & Plasmid generation
  • EPIC-2BOX Mammalian cell（EPIC-CHOTM）
    • Mammalian cell（EPIC-CHO™）
    • Microbial
  • Vector design and construction
  • Single-clone screening
  • Cell bank preparation and characterization study
  • Genetic stability study
  • pDNA
  • RCB (Research Cell Bank)
Analytical Assays Development
  • Analytical Assays Development
    • Identity testing
    • Determination assays
    • purity testing
    • Safety testing assays
    • Activity testing assays
    • Impurity residue testing assays
  • Analytical Assays Transfer
  • Analytical Assays confirmation and Validation
Process development
Cell bank preparation (MCB/WCB)
  • Microbial/Mammalian cell banking
  • MCB/WCB preparation and characterization
  • Genetic stability study of the cell bank
  • Storage and temperature monitoring under GMP conditions
Tech Transfer/ GMP manufacturing
  • Tech Transfer/Process development
  • Analytical assays transfer and validation
  • Raw material procurement and release
Pilot/Clinical phase manufacture (GMP)
IND Filings
  • China
  • US
  • European Union (EU)
  • Other: Australia, etc.
Process characterization study (PC)
  • Building and validation of the scale-down model
  • FMEA&DoE
  • Definition of CPP&KPP
  • Establish control strategy
  • Resin lifecycle study
PPQ（PV）
  • PV batch production (DS/DP)
  • GMP release and stability study
NDA/BLA
PAI support
  • China: NMPA
  • US: FDA
  • Europe: EMA
  • Other: ANVISA/TGA, etc.
Commercial launches
  • DS
  • DP
    • Liquid vial
    • Pre-filled syringe
    • Lyophilization
    • Cartridge
    • other
  • DS/DP GMP Release and stability study
Engineering service
Sequence Confirmation
Cell line/Strain development & Plasmid generation
Analytical Assays Development
Process development
Cell bank preparation (MCB/WCB)
Tech Transfer/ GMP manufacturing
Pilot/Clinical phase manufacture (GMP)
IND Filings
Process characterization study (PC)
PPQ（PV）
NDA/BLA
PAI support
Commercial launches
Engineering service
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