Process Development
Bioprocess development built with QbD and DoE from the start. We develop upstream and downstream processes around your molecule’s actual behavior — titer, aggregation, clearance, yield — and hand over a defined design space rather than a single set of conditions that happened to work.
OVERVIEW
- Cell culture process technology platform provides for optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, enhance process reproducibility and facilitate scale-up.
- Adaption of cell line to suspension culture process
- Adaption of cell line to serum-free/animal protein-free media
- Media optimization and evaluation
- Development of Fed-batch bioreactor process
- Cell culture characterization and optimization
- Scale-up
- Analysis of risk and cost benefits for various types of cell culture processes
Mammlian Cell Culture Systems:
- Flasks (all types)
- Spinner / Shake Flasks
- Wave- and Stir-Form Bioreactors
- 3L & 15L bioreactors (Applikon)
- 2 x Wave-form Bioreactors: 2L – 25L capacity(GE)
- 1 x 50-liter & 1x200L&1 x 250L Single-Use Bioreactor(Hyclone & GE)
- Cell Culture Analyzers
- 1 x Bioprofile Flex2 (Nova Biomedical)
- 1 x Bioprofile 400 (Nova Biomedical)
- 1 x Vi-Cell (Beckman Coulter)
- Cell Culture Clarification
- Depth Filtration
- Centrifugation
The platform process for MAb is:
- Depth filtration
- Pro A + low pH inactivation + filtration
- Cation or Anion exchange chromatography
- Virus filtration
- Ultra-filtration
- Use this process to remove HCP/HCDNA/Aggregation and control charge variant.
- During process development, each unit operation CPP will be developed with design space.
- Linear scale up from bench to 10, 50 and 250L related scale, the process description will be transferred into batch records for pilot scale.
- All the CQAs and recovery will be monitored during scale up to dial in the TPP.
