Biologics
Drug Substance & Development
From Bench through Commercialization
As part of our extensive contract development and manufacturing service offerings we use advanced technologies and innovative solutions to efficiently develop and manufacture compliant and quality products, including monoclonal antibodies, complex proteins, and recombinant proteins.
Cell Line Development
Cell Line Development Services
- Cell line generation
- Clone screening
- Cell line selectionCell banking services (Research and GMP)
- Options for GS (Glutamine Synthetase) knock-out cell line with robust and highly productive titers
Drug Substance Process Development
- Bioreactor development including batch versus fed batch
- High-throughput protein purification process development
- Non-GMP and GMP Pilot (200L / 500L) manufacture capacities
- Stability on drug substance
Drug Product Development
- QbD formulation screening
- Stability studies
- Non-GMP / GMP pilot aseptic liquid filling