|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) || |
- 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.