- 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.
- 使用悬浮培养细胞体系
- 使用无血清/动物蛋白来源的培养基体系
- 生物反应器补料培养体系的优化
- Development of Fed-batch bioreactor process
- 工艺放大
- 工艺放大
- 使用多平台的CHO细胞体系供客户选择以达到平衡风险和降低成本效益的目的
Mammlian Cell Culture Systems:
- • 烧瓶（所有类型）
- 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
- • 离心
The platform process for MAb is:
- • 深度过滤
- Pro A + low pH inactivation + filtration
- 阳离子或阴离子交换色谱
- 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.
