ProBio Inc, a China-based global contract research, development and manufacturing organisation (CRDMO), announced on Wednesday the successful completion of a Pre-Approval Inspection (PAI) by China's National Medical Products Administration (NMPA) at its biologics manufacturing facility in Nanjing, China.

ProBio's biologics platform is designed to support customers throughout the development and manufacturing lifecycle, from early-stage development and IND-enabling activities through clinical development, BLA submission and commercial manufacturing.

The successful PAI follows continued investment in manufacturing infrastructure, quality systems, analytical capabilities and operational capacity at the Nanjing facility. ProBio's quality system supports compliance with applicable regulatory requirements across major global markets, including the United States, Europe and China, with quality practices designed to meet the expectations of agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and NMPA.