• 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.