Drug Substance (DS) Process Development
Led by a team of experts, we offer batch and fed-batch (including high-density fed-batch), and downstream purification process development of molecules in different expression systems. This includes, but is not limited to, intracellular soluble products, inclusion bodies, and extracellular secreted products. Our multi-purpose/multi-product 2,000 m2 process development laboratories facilitate the development of nucleic acid or protein biotherapeutics and vaccines, supporting IND-enabling toxicology studies, or preclinical and CMC development activities at various scales.
Our capabilities include:
- Clone selection support
- Fermentation process development
- Purification process development
- Process verification for direct technical transfer
- Non-GMP and pilot production
- Scale-up , technical transfer and clinical manufacturing support
- Process characterization, optimization and validation
- IND/IMPD & BLA filing support