- GMP and GLP Quality Systems
- IND, NDA, and BLA CMC Preparation
- Contractor Auditing
- Process and Analytical Validations
- Facility Design
- Formulation Development
- Stability Protocol Development
- Mammalian & Microbial Cell Production
- Monoclonal Antibody Production and Purification
- Recombinant Protein Production and Purification
- Bioreactor Design
- Fermentation
- Cost and Process Analysis
|