Bring your sequence, we’ll take you to IND
From development to clinical and commercial, we work with commercialization in mind. Our development experts generate and optimize scalable, robust process for reliable support of our clients’ clinical and long-term commercial supply.
By connecting all aspects of development to clinical and commercial production, we are able to achieve optimal yield, quality, and stability for a reliable clinical supply.
- Discovery
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- S-DUAL™ - Bispecific Antibody Platform
- DEVELOPICK™ - Developability Assessment Platform
- Cell Line
Development -
- S-CHOice® and CHOZN® Platforms
- High productivity with titers up to 7.0g/L
- Process
Development -
- Media screening and process optimization
- Buffer and excipient screening
- Assay development and characterization studies
- Non-GMP DS/
DP Production -
- Scale: 50L or 200L bioreactors
- Non-GMP DS/DP stability data to support cGMP DS/DP stability
- cGMP DS/
DP Production -
- Scale: 200L and 1,000L bioreactors
- DS/DP stability study
- In-house, clinical- scale DS/DP manufacturing
- IND Filing
Support -
- IND/IMPD CMC documentation support
- IND filing support with Module 2.3 & 3 of CTD and Type V drug Master File