- ProBio has launched cGMP adeno-associated virus (AAV) manufacturing services at its new 128,000 sq. ft. facility in Hopewell, New Jersey.
- The site offers fully integrated, single-site solutions from plasmid production to final fill/finish, aimed at accelerating gene therapy development timelines.
ProBio, a contract development and manufacturing organisation (CDMO) specialising in gene and cell therapy, has introduced current Good Manufacturing Practice (cGMP) adeno-associated virus (AAV) manufacturing services at its 128,000 sq. ft. facility in Hopewell, New Jersey. The expansion is intended to address increasing demand for high-quality viral vector production.
The Hopewell site is designed to deliver end-to-end AAV manufacturing solutions in line with global regulatory and quality standards. Capabilities include GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation and aseptic fill/finish. All services are offered within a single U.S.-based location to simplify coordination, reduce handoffs, and shorten development timelines.
ProBio’s platform supports batch sizes from 50L to 200L, with the ability to run 2x200L batches concurrently, covering early clinical to late-phase programmes. The company has also implemented a fully electronic Quality Management System (QMS) powered by Veeva for real-time documentation control, aiming to enhance operational efficiency and compliance.
“The launch of our GMP AAV manufacturing platform reflects our mission to help developers navigate complex manufacturing challenges with speed, precision, and scientific integrity,” said Allen Guo, Chief Executive Officer of ProBio.
The facility’s team has experience in biologics and viral vector manufacturing, including the development and commercialisation of approved therapies. ProBio intends for its integrated approach, coupled with a U.S.-based supply chain and in-house analytics, to support faster, phase-appropriate release of gene therapy products.
