GenScript ProBio provides open, coordinated and innovative one-stop biopharmaceutical platform for China and global customers, helping customers accelerate the development process from drug discovery to IND application.
The Nanjing Biologics R&D Center provides one-stop CDMO services from target to IND application. This center has Biopharmaceutical R&D Laboratory and GMP pilot scale manufacturing workshop.
Nanjing Bio-MFG Center includes GMP warehouse, DS production workshop and high standard QC lab and meets the regulatory requirements of China, the United States and Europe, and has successfully passed the European Union QP audit. It provides GMP manufacturing services for clinical phase I and II projects.
Nanjing Bio-MFG Center has total culture volume of 2,200L and 80 batches per year. This center can provide fully single-use GMP clinical manufacturing services and multiple samples can be produced simultaneously.
The building has closed, disposable adherent process; well-developed suspension system reduces cost of viral vector production and >130 projects on going, including P&V CMC and GMP manufacturing for clinical supply.
Provide gene & cell therapy customers with plasmid and viral vector manufacturing and process development services, to cover the needs from IIT, IND application, and clinical trials
GMP warehouse conforms to the requirements of NMPA/FDA for material storage.Plasmid GMP manufacturing center meets the requirements of early clinical and commercial production for domestic and American customers. It is equipped with 2X30L and 1X300L single-use bioreactors and 2 down-stream purification, with the max capacity of 48 batches.