ProBio Successfully Completes Pre-Approval Inspection of China Biologics Manufacturing Facility

Editor’s Take: Successful completion of ProBio’s China inspection proves the bona fides of the company’s quality systems and other operations.

ProBio, a global CRDMO, successfully completed Pre-Approval Inspection (PAI) of its biologics manufacturing facility in Nanjing, China. China’s National Medical Products Administration (NMPA) performed the inspection.

According to ProBio, this is a key milestone to continue expanding biologics good manufacturing practice (GMP) capabilities and regulatory readiness.

Any successful PAI completion demonstrates a facility’s quality systems robustness, as well as manufacturing operations. For ProBio, they desire proving these characteristics—alongside regulatory compliance—to support biopharmaceutical programs advancing toward clinical and/or commercial manufacturing.

ProBio Looking for What Partners Need

Manufacturing readiness has become increasingly important to biopharmaceutical companies as their programs near regulatory approval.

“This milestone reflects the strength of our quality organization and biologics manufacturing operations,” ProBio CEO Allen Guo said.

Guo also stressed the inspection’s relevance to investments ProBio has made to build a reliable platform for customers nearing commercialization.

“They need a partner with the capabilities, quality systems, and operational discipline to support increasingly demanding regulatory requirements,” Guo said. “This achievement reinforces our commitment to being that partner.”

To further specify, ProBio’s platform supports customers throughout the development and manufacturing lifecycle. This spans from early-stage development and Investigational New Drug-enabling activities through clinical development, Biologics License Application submission, and commercial manufacturing.

China Site’s Main Features

Key capabilities ProBio offers through the Nanjing site start with cell line, upstream and downstream process, analytical, and formulation development. They then encompass technology transfer and scale-up, GMP biologics manufacturing, and quality and regulatory support.

Overall, ProBio offers solutions across antibodies, mRNA, plasmid DNA, viral vectors, and in-vivo CAR-T therapies.