ProBio launches cGMP AAV manufacturing at New Jersey facility

Aug. 15, 2025

ProBio, a contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, has launched current Good Manufacturing Practice (cGMP) adeno-associated virus (AAV) manufacturing services at its 128,000-square-foot facility in Hopewell, New Jersey. The expansion is intended to meet increasing demand for viral vector production.

The Hopewell site was built to provide end-to-end AAV manufacturing capabilities that the company said align with global regulatory and quality standards. Services include GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation and aseptic fill/finish in one location. The company said this approach can reduce handoffs and streamline coordination during drug development.

The facility’s manufacturing platform reportedly offers flexible batch sizes from 50 liters to 200 liters, with the ability to run 2x200L batches concurrently to support early clinical through late-phase programs. Additional features include domestic sourcing for key raw materials, internal quality control and analytical testing, and a fully electronic quality management system powered by Veeva for real-time approval and traceability of GMP documentation.

“Our processes are engineered to support a wide range of serotypes, production scales, and clinical milestones — while ensuring rigorous in-process controls and regulatory alignment at every step,” Lance Marquardt, director of AAV manufacturing operations at ProBio, said in a statement.