- ProBio completed a Pre-Approval Inspection (PAI) by China’s National Medical Products Administration (NMPA) at its biologics manufacturing facility in Nanjing, China.
- The company supported a customer program from the investigational new drug (IND) stage through biologics license application (BLA) submission, as the program progressed toward commercialization.
ProBio Inc., a global contract research, discovery, development and manufacturing organization (CRDMO), has completed a Pre-Approval Inspection (PAI) by China’s National Medical Products Administration (NMPA) at its biologics manufacturing facility in Nanjing, China. The inspection marks a milestone in the company’s efforts to expand its biologics good manufacturing practice (GMP) manufacturing capabilities and regulatory readiness.
The successful inspection reflects the facility’s quality systems and manufacturing operations as ProBio supports biopharmaceutical programs progressing toward clinical and commercial manufacturing. The company said the achievement follows continued investment in manufacturing infrastructure, quality systems, analytical capabilities and operational capacity.
ProBio supported the customer associated with the program from the IND stage through BLA submission, providing services across the development and manufacturing lifecycle. Its biologics platform includes cell line development, upstream and downstream process development, analytical development and characterization, formulation development, technology transfer, scale-up, GMP manufacturing, and quality and regulatory support.
“This milestone reflects the strength of our quality organization and biologics manufacturing operations, as well as the investments we have made to build a reliable platform for our customers. The achievement reinforces the company’s commitment to supporting customers as their programs move toward commercialization and face increasingly demanding regulatory requirements.”
Allen Guo, CEO of ProBio
ProBio said its quality system is designed to support applicable regulatory requirements across major markets, including the United States, Europe and China. The company combines its biologics manufacturing capabilities in China with a growing global commercial and technical organization to support biopharmaceutical customers across development and manufacturing.
