TJAB·GMP Equivalent Facility for Biologics
Reference: tjab Time:2016-09-29 16:05
The TJAB GMP Facility for Biologics (Bio-GMP platform) is designed to meet all the GMP standards of China (CFDA), USA (FDA) and EU (EMA). For process development and GMP pilot scale experiment, Bio-GMP platform is equipped with first-class production facilities that can develop and manufacture monoclonal antibodies, recombinant proteins, vaccines, and blood products. Supported by this open-type technical platform, we provide professional contract research services on biomedical projects for various clients.
Services include:
Establishment of cell repository;
Development of biologic production process and pharmaceutical quality standard ,injection and lyophilized powder production;
Samples for formulation development, preclinical pharmacology, toxicology, pharmacokinetics and pharmacodynamics;
Samples for the permission of clinical trial;
Medications for Phase I, II, III clinical trials;
Registration of manufacturing process of market drugs, clinical drug candidates and on-site GMP verification of biomedical products to international drug regulatory agencies (like FDA);
Contract manufactory services of large scale production of bio-medicines.
