The Hopewell manufacturing facility. [Image courtesy of ProBio]
The company added the services at its 128,000-square-foot, state-of-the-art facility to meet growing industry demand for high-quality viral vector production. It said the additional capacity reflects its ongoing commitment to supporting the advancement of life-changing gene therapies.
ProBio built its Hopewell facility to provide end-to-end AAV manufacturing solutions that align with global regulatory and quality standards. It offers clients fully integrated services, 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. The company says its streamlined approach simplifies coordination, reduces handoffs and accelerates timelines across the drug development lifecycle.
To enhance operational effectiveness, ProBio utilized a fully electronic Quality Management System (QMS) powered by Veeva. The system enables real-time electronic approval and traceability of key GMP documentation. That includes batch records, deviations, change controls and CAPA events to support both regulatory alignment and execution speed.
“At ProBio, we recognize that every gene therapy program represents a critical opportunity to change lives,” said Allen Guo, CEO of ProBio. “Our new GMP AAV manufacturing platform reflects our mission to help developers navigate complex manufacturing challenges with speed, precision, and scientific integrity.”
Tell Us What You Think!