Biologics Contract Manufacturing Capabilities
We offer comprehensive biologics development and manufacturing services from some of the world’s most advanced production facilities, applying the most sophisticated equipment, technologies and processes to your project.
- Cell line development (MCB/WCB)
- Upstream/downstream process development, optimization and scale-up
- Stability studies and analytical characterization
- cGMP manufacturing
- Regulatory guidance and support including filing and global marketing approval
- Structured project management
- Process justification/process validation
Cell Culture Manufacturing
In biologics manufacturing, success is measured largely by product reproducibility. Through sophisticated cell line development, cell culture manufacturing and quality control processes, we can help you overcome the complexity of large molecule manufacturing to deliver consistent drug performance. Let our excellent track record of biopharmaceutical process development set the foundation for a sustainable, reliable biologics program and ongoing supply of your drug product.
Analytical Services
- HPLC (SEC, IEX, affinity, reverse phase)
- Host cell protein
- Electrophoresis (CE, IEF, SDS-PAGE)
- ELISA
- Peptide structure determination (LC, MS)
- Oligosaccharide analysis
- DNA quantification (threshold)
- DNA identification (PCR)
- Spectrophotometry (FT-IR, UV VIS)
- Bioburden / endotoxin
Client Services
- Stability studies
- Regulatory filing expertise
- Project management and inventory planning
- Scale to accommodate multiple customers simultaneously
- Dedicated time slots for strategic partners
- Exceptional track record of achieving timelines
- History of facility expansion for growing demands