ProBio, a contract research, development and manufacturing organization (CRDMO) headquartered in New Jersey, has completed a pre-approval inspection by China’s National Medical Products Administration (NMPA) at its biologics manufacturing facility in Nanjing, China. The inspection marks a regulatory milestone for the facility as it supports biologics programs progressing toward commercial manufacturing, according to the company.

ProBio said it supported the customer associated with the inspected program from the investigational new drug (IND) stage through biologics license application (BLA) submission. The CRDMO provides biologics development and manufacturing services spanning cell line development, process and analytical development, formulation, technology transfer, and Good Manufacturing Practice (GMP) production.

The company said its quality systems are designed to support regulatory requirements in China, the United States, and Europe. Completion of the inspection adds to its manufacturing track record as it seeks to support customers moving biologics programs from development into commercial production.

The development follows ProBio’s expansion of its U.S. manufacturing capabilities. In August 2025, the company launched GMP adeno-associated virus (AAV) manufacturing at its 128,000-square-foot facility in Hopewell, New Jersey. The site offers viral vector production, plasmid DNA manufacturing, formulation and aseptic fill-finish services for gene therapy programs.

ProBio said it continues to invest in manufacturing infrastructure, analytical capabilities, and quality systems to support biologics and advanced therapy programs across development and manufacturing stages.