PacificGMP excels at upstream and downstream process development.
Process development services can stand alone or be integrated into preclinical and clinical manufacturing projects.
PacificGMP focuses on improving yield at each stage of development by optimizing each step in the process.
Cell Line Development
- Expression vector and plasmid construction
- Cell line initiation through transfection and selection
- Clonal selection
- Amplification
- Suspension and serum-free adaptation
- Cell culture media optimization
Upstream Process Development
- Cell line expansion and cell banking
- Production scale-up from 100 ml to 500 liters with batch and fed-batch modes, up to 15,000 liters with perfusion mode
- Single-use production devices utilized for adherent and suspension cells
- Specialize in developing entirely single-use upstream bioprocessing systems
Downstream Process Development
- Optimization of clarification, concentration, viral clearance, purification and diafiltration
- Development and scale-up with an emphasis on closed systems employing single-use technology
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