ProBio Launches cGMP AAV Manufacturing Services at Hopewell, NJ Facility

ProBio, a contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, has launched cGMP Adeno-Associated Virus (AAV) manufacturing services at its 128,000 sq. ft. facility in Hopewell, New Jersey.

The Hopewell facility is purpose-built to provide end-to-end AAV manufacturing solutions that align with global regulatory and quality standards. ProBio’s new capabilities offer clients fully integrated services—including GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation and aseptic fill/finish—within a single U.S.-based location.

“At ProBio, we recognize that every gene therapy program represents a critical opportunity to change lives,” said Allen Guo, Chief Executive Officer of ProBio. “Our new GMP AAV manufacturing platform reflects our mission to help developers navigate complex manufacturing challenges with speed, precision, and scientific integrity.”

The Hopewell team brings decades of experience in biologics and viral vector manufacturing, with a track record of supporting the development and commercialization of approved therapies.

“The launch of our GMP AAV services is the result of deep cross-functional collaboration and reflects our commitment to delivering high-quality, end-to-end solutions for our partners,” said Michael Vreeland, U.S. Site Head. “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.”

Key Features of ProBio’s GMP AAV Manufacturing Services include:

• Scalable, Phase-Appropriate Manufacturing: Flexible batch sizes from 50L to 200L, with capability for 2x200L concurrent runs—supporting early clinical to late-phase programs.
• Fully Integrated Platform, Single-Site Solutions: From plasmid production and AAV vector manufacturing to final drug product fill/finish, ProBio streamlines the entire process under one roof.
• Resilient U.S.-Based Supply Chain: By prioritizing domestic sourcing for key raw materials, ProBio ensures greater supply stability, faster lead times, and quality.
• Accelerated Timelines Through In-House Analytics: Comprehensive internal QC and analytical capabilities enable fast, phase-appropriate release while maintaining precision and compliance.

Earlier this year, ProBio also launched a GMP Plasmid DNA manufacturing service at its facility in Hopewell.