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.
