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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
R&D Services
02
Quality Service
  • Quality Control
  • Quality Management
Quality Service
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
Manufacturing Service
04
Regulatory Service
  • IND
  • CMC Regulatory Filing
  • BLA / MAA
  • China-US-EU Multi-region Filing
Regulatory Service