Process Development

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  • 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.

Headquarters

1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203

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Europe: +45 4586 9000
Japan: +81 03 5403 6975

contact@chempartner.com