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.
OVERVIEW
Everything a sponsor evaluating an outsourced biologics CMC partner needs to know — from capacity to compliance.
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
