• 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.