GMP Production
GMP production of biologics from a single connected CDMO. Cell line, upstream, downstream, formulation and fill-finish run under one quality system across 50L to 2000L, so analytics and regulatory documentation stay with your molecule through every scale change.
概述
赞助商在评估生物制剂CMC外包合作伙伴时需要了解的一切——从产能到合规性。
Pilot scale capacities in Zhangjiang, Shanghai
- Capable of generating 500-1000g of DS per batch to meet pre-IND and phase I &II clinical demand
- Aseptic fill 2- 20 ml vials, up to 900-1800 vial/hr and 5000 vials per batch; 2.8m² freeze-drying shelf area for DP
GMP Manufacturing in Qidong, Jiangsu
- 2x2000L Fed batch; 1×500 L Fed Batch, up to 200KG for DS
- 10000 bottle/batch aspect filling line for vials and PFS; 25 m² freeze-drying line for DP
