ProBio, a leading contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, has announced the launch of its cGMP Adeno-Associated Virus (AAV) manufacturing services at its 128,000 sq. ft. state-of-the-art Hopewell, New Jersey facility. This expansion addresses growing demand for high-quality viral vector production and demonstrates ProBio’s commitment to advancing life-changing gene therapies.
The Hopewell site is purpose-built to provide fully integrated, end-to-end solutions—including GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation with aseptic fill/finish—within one U.S.-based location. This approach minimizes handoffs, reduces complexity, and accelerates timelines while ensuring global regulatory and quality compliance.
Key features include scalable, phase-appropriate manufacturing from 50L to 200L, with the capability for 2x200L concurrent runs to support early clinical through late-phase programs; a resilient U.S.-based supply chain with prioritized domestic sourcing; and in-house QC analytics to enable faster, compliant product release. ProBio also leverages a fully electronic Quality Management System (QMS) powered by Veeva, allowing real-time electronic approvals, traceability, and efficient GMP documentation control.
The experienced Hopewell team has decades of hands-on expertise in biologics and viral vector manufacturing, having supported development and commercialization of approved therapies. The new GMP AAV platform is designed for flexibility, supporting multiple serotypes, production scales, and clinical milestones, with built-in quality by design to meet the evolving needs of each gene therapy program.