transreco
服务范围
主要提供CHO、HEK293细胞/E.coil/酵母表达的重组生物产品研发和生产服务;
符合GMP(2010年修订)和FDA、欧盟EMA标准,并参照国际制药工程协会ISPE相关法规。
01
R&D Services
- Molecular Construction
- Process Optimization & Process Characterization
- Small-scale Process Development
- Pilot Scale-up
- Pilot Scale-up
- Resin & Membrane Lifetime Assessment
02
Quality Service
- Quality Control
- Quality Management
03
Manufacturing Service
- Eukaryotic Drug Substance: 50L / 250L / 500L (ATF) / 2000L
- Prokaryotic Drug Substance: 100L / 50L+500L / 50L+250L+2000L
- Sterile Formulations: Injections, gels, ophthalmic preparations, inhalants
04
Regulatory Service
- IND
- CMC Regulatory Filing
- BLA / MAA
- China-US-EU Multi-region Filing