HOPEWELL, N.J., Oct. 21, 2026 -- ProBio Inc., a global contract research, discovery, development and manufacturing organization (CRDMO), today announced 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, marking an important milestone in the company's continued expansion of its biologics GMP manufacturing capabilities and regulatory readiness.
The successful inspection underscores ProBio's commitment to robust quality systems, manufacturing excellence and regulatory compliance as it supports biopharmaceutical programs advancing toward clinical and commercial manufacturing. For biopharmaceutical companies, manufacturing readiness becomes increasingly important as programs progress toward regulatory approval. Successful completion of a PAI provides an important demonstration of the facility's quality systems, manufacturing operations and readiness to meet the regulatory expectations associated with the inspected product and manufacturing process.
"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," said Allen Guo, CEO of ProBio. "As our customers advance programs toward commercialization, they need a manufacturing partner with the capabilities, quality systems and operational discipline to support increasingly demanding regulatory requirements. This achievement reinforces our commitment to being that partner."
Supporting Customers from IND to BLA and Beyond
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. For this program, ProBio supported the customer from the IND stage through BLA submission, working alongside the customer as the program progressed toward commercialization. This long-term collaboration reflects ProBio's approach to growing together with its customers, building capabilities, manufacturing readiness and regulatory support alongside the evolving needs of each program. By providing continuity across development, technology transfer, GMP manufacturing and regulatory milestones, ProBio helps customers reduce complexity and maintain momentum as programs advance through increasingly demanding stages of development.
Demonstrating Biologics Manufacturing and Quality Readiness
The successful PAI is an important milestone for ProBio's Nanjing biologics manufacturing facility and follows continued investment in manufacturing infrastructure, quality systems, analytical capabilities and operational capacity. ProBio's quality system is established to support 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 U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and NMPA. ProBio provides integrated biologics development and manufacturing capabilities designed to support programs from early development through clinical and commercial stages.
Key biologics capabilities include:
- Cell line development establishing the regulatory-compliant, stable, and high-producing clone as a foundation for scalable manufacturing
- Upstream and downstream process development to establish robust, scalable manufacturing processes
- Analytical development and characterization supporting product understanding, process development and regulatory requirements
- Formulation development supporting stable, scalable, and submission-ready formulations for both biologics drug substance and drug product programs
- Technology transfer and scale-up connecting development activities with GMP manufacturing
- GMP biologics manufacturing supporting clinical and commercial programs
- Quality and regulatory support across development, manufacturing and regulatory milestones
Together, these capabilities are designed to provide sponsors with greater continuity from development through GMP manufacturing while reducing complexity as programs advance.
Supporting Programs Toward Commercial Manufacturing
As biopharmaceutical companies increasingly evaluate CRDMO partners for late-stage and commercial programs, manufacturing track record, quality systems and regulatory readiness are important considerations in partner selection. The successful PAI of ProBio's Nanjing, China biologics manufacturing facility adds to the company's growing manufacturing track record and supports its continued expansion as a global partner for biopharmaceutical companies developing and commercializing biologic medicines. For US and European sponsors, ProBio combines its biologics manufacturing capabilities in China with a growing global commercial and technical organization, providing customers with access to integrated development and manufacturing expertise and global program support.
Building a Global Biologics Manufacturing Platform
The successful PAI is part of ProBio's broader investment in its biologics manufacturing platform and global infrastructure. ProBio continues to expand its capabilities to support customers across the biologics development lifecycle, with a focus on manufacturing quality, operational scalability, supply continuity and regulatory readiness. "Maintaining strong quality and manufacturing performance is fundamental to our strategy," said Allen Guo. "This milestone demonstrates the progress we are making in building a biologics manufacturing platform that customers can rely on as their programs move toward commercialization."
Partner with ProBio
Planning the next stage of your biologics manufacturing program? Connect with ProBio to explore how our integrated biologics development and GMP manufacturing capabilities can support your program from cell line development through clinical and commercial supply.
Explore ProBio's manufacturing capabilities: IND to BLA CMC & Biologics Commercialization | ProBio
About ProBio
ProBio is a global Contract Research, Discovery, Development and Manufacturing Organization (CRDMO) enabling biotech and pharmaceutical companies to advance the development and manufacturing of next-generation therapies. With expertise across biologics, cell and gene therapy, ProBio delivers integrated development and manufacturing solutions spanning antibodies, mRNA, plasmid DNA, viral vectors and in vivo CAR-T therapies.
ProBio's scalable, GMP-compliant platforms support partners from early discovery, process development through commercial manufacturing, helping accelerate timelines and de-risk complex development programs. Through a collaborative partnership approach, ProBio works closely with customers to advance programs from scientific development through regulatory and commercial milestones.
For more information, visit www.probiocdmo.com
