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Service

Drug Substance MFG.

Item What We Have, Do, Provide
Clone Construction
  • Provide the service of clone construction with the consideration of global requirement from the perspectives of cost and regulation.
Upstream Process (Mammalian cell culture)
  • Experienced with cell banks establishment and repository control per GMP.
  • GMP compliant backup storage in multiple sites.
  • Contract and manage the safety and/or characterization study;experienced in cooperation with well-known GLP CROs.
Cell Bank Establishment
  • Experienced in batch, fed batch and perfusion production. Fed batch: ~5g/L (CHO).
  • Perfusion: maintain high density (>1x107cells/ml) and high output (>500mg/L) growth over 30 days (100L/day, >3000 L/lot).
  • Concentrated perfusion: ~ 10g/L (CHO).
  • High density production: cell density >5 x107cells/ml
  • 100% single use tech. applied; the concern on clean validation and cross contamination is diminished to the utmost.
  • Bioreactor: biowave (50/200L) and stir tank (50/200/500/2,000L).
  • Serum free and animal source free medium used.
  • Establish a design of experiment (DOE)-based medium screening platform; benefiting yield and cost control.
Upstream Process (Microbial fermentation)
  • Fermenters:
    - 50L turbo SUB, 7.5L SSU.
    - 5000L with alliance.
  • Conduct high density growth under animal source free and antibiotics free condition.
  • Established a DOE-based medium screening platform; benefiting yield and cost control.
Downstream Process
  • Achieved bulk ~2.5 kg / lot.
  • Experienced in process scale-up.
  • Experienced in ANC, IEC, HIC, and SEC chromatography and various scale size of columns.
  • Experienced in ultrafiltration/ diafiltration (TFF system), and nanofiltration.
  • Experienced in design and conduct viral clearance validation.
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