Large molecule pilot and large-scale production platform
I Platform Introduction
The large molecule pilot and large-scale production platform is a CRO/CMO platform for macromolecular drugs that meets the FDA, EMA and NMPA GMP standards. It aims to provide integrated CDMO services for the development and production of biological macromolecular drugs.
Service: Stable cell line screening, pilot-scale fermentation process, large-scale culture process and macromolecular purification process development services, antibody drugs, recombinant protein drugs, protein vaccine pilot-scale and large-scale production services, production technical services for biomacromolecule drug preparation, support products to conduct clinical trials in China, the US, Europe and other places and quickly go to market, realizing the global synchronization of customers' research results.
II Platform Function Introduction
The platform has 4 floors and a total construction area of 11453 m2.
III Platform Hardware Introduction
Pilot process development laboratory, 500L/2000L scale production line (NEPHARM team design, cGMP standard, equipped with Sartorius bioreactor, Millipore three filtration system and GE purification system, Bosch washing-drying-filling-rolling line, 3M sterilization cabinet and Schneider SCADA automation control system)