ProBio, a contract development and manufacturing organization (CDMO) specialising in gene and cell therapy, has announced the launch of its cGMP Adeno-Associated Virus (AAV) manufacturing services at its 128,000 sq. ft. state-of-the-art facility in Hopewell, New Jersey.

This strategic expansion is designed to meet growing industry demand for high-quality viral vector production and reflects ProBio's ongoing commitment to supporting the advancement of life-changing gene therapies, the company said in a statement

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 US-based location. This streamlined approach simplifies coordination, reduces handoffs, and accelerates timelines across the drug development lifecycle.

“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 hands-on experience in biologics and viral vector manufacturing, with a track record of supporting the development and commercialisation 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, US 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.”

ProBio offers scalable, phase-appropriate manufacturing with flexible batch sizes ranging from 50L to 200L, and the capability for 2x200L concurrent runs, supporting programs from early clinical stages through late-phase development. Its fully integrated, single-site platform covers everything from high-quality plasmid production and AAV vector manufacturing to final drug product fill/finish, streamlining the process, reducing complexity, saving time, and accelerating the path to clinic.

With a resilient US-based supply chain that prioritizes domestic sourcing for key raw materials, ProBio ensures supply stability, faster lead times, and consistent quality, enabling gene therapy developers to move forward with confidence. Additionally, in-house analytics and comprehensive internal QC capabilities facilitate accelerated timelines and phase-appropriate release while upholding the highest standards of precision and compliance.

To enhance operational effectiveness and ensure seamless compliance, ProBio has embraced digitalisation through the implementation of a fully electronic Quality Management System (QMS) powered by Veeva. This system enables real-time electronic approval and traceability of key GMP documentation, including batch records, deviations, change controls, and CAPA events—supporting both regulatory alignment and execution speed.

“What differentiates our AAV platform is the combination of flexible manufacturing architecture and built-in quality by design,” said Lance Marquardt, Director of AAV Manufacturing Operations at ProBio. “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.”