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.