ProBio, a contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, has announced the launch of its cGMP (current Good Manufacturing Practices) Adeno-Associated Virus (AAV) manufacturing services at its state-of-the-art facility in Hopewell, New Jersey. This 128,000-square-foot facility is designed to meet the growing demand for high-quality viral vector production, supporting the advancement of life-changing gene therapies.
Integrated, Single-Site Solutions for Streamlined Development
The Hopewell facility is purpose-built to provide end-to-end AAV manufacturing solutions that adhere to global regulatory and quality standards. ProBio’s new services offer clients a fully integrated platform, including GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation and aseptic fill/finish, all within a single U.S.-based location. This streamlined approach is designed to simplify coordination, reduce handoffs, and accelerate timelines for drug developers.
Scalable Manufacturing and Digitalized Quality Management
ProBio’s GMP AAV manufacturing services feature flexible batch sizes from 50L to 200L, with the capability for concurrent runs, which supports programs from early clinical stages to late-phase development. The company has also embraced digitalization by implementing a fully electronic Quality Management System (QMS) powered by Veeva. This system enables real-time electronic approval and traceability of critical documentation, such as batch records and change controls, to ensure seamless compliance and execution speed.
The company’s team at Hopewell has extensive experience in biologics and viral vector manufacturing, with a history of supporting the development and commercialization of approved therapies. ProBio’s processes are engineered to support a wide range of serotypes, production scales, and clinical milestones, with a focus on rigorous quality control and regulatory alignment at every step.
