ProBio, a Hopewell-based contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, officially launched its cGMP Adeno-Associated Virus (AAV) manufacturing services at its state-of-the-art 128,000 sq. ft. facility.
This expansion directly addresses the growing industry demand for high-quality viral vector production, reinforcing ProBio’s dedication to advancing life-changing gene therapies.
The Hopewell facility is designed as a comprehensive, single-site solution for AAV manufacturing. It offers fully integrated services that adhere to global regulatory standards, including GMP plasmid DNA production, AAV vector manufacturing and final drug product formulation with aseptic fill/finish. This approach is a key differentiator, as it simplifies complex logistics, reduces handoffs between multiple vendors and accelerates the entire drug development timeline.
According to ProBio’s CEO, Allen Guo, the new manufacturing platform is a direct reflection of the company’s mission to support developers in overcoming manufacturing challenges with “speed, precision, and scientific integrity.” The team at the Hopewell facility brings decades of experience in biologics and viral vector manufacturing, with a proven track record of supporting the development and commercialization of approved therapies.
“Our experts have built and scaled manufacturing systems for some of the industry’s most advanced therapeutics, and they’re now applying that same expertise and dedication to every program at ProBio,” Michael Vreeland, the U.S. Site head, said.
The new services feature scalable, phase-appropriate manufacturing, with flexible batch sizes from 50L to 200L, and the capacity for concurrent runs to support programs from early clinical stages to late-phase development. ProBio has also implemented a resilient, U.S.-based supply chain to ensure stability and quality of raw materials. To further enhance efficiency and compliance, a fully electronic Quality Management System (QMS) has been integrated, providing real-time traceability and faster regulatory alignment.
Lance Marquardt, Director of AAV Manufacturing Operations, highlighted the platform’s core advantage: “What differentiates our AAV platform is the combination of flexible manufacturing architecture and built-in quality by design.” He noted that the processes are engineered to support a wide range of serotypes and production scales, while maintaining rigorous controls.
