Image Credit: ProBio

ProBio, a contract development and manufacturing organization (CDMO) that focuses on cell and gene therapy (CGT), has debuted its current good manufacturing practice (cGMP) adeno-associated virus (AAV) manufacturing services at its 128,000 square-foot Hopewell, NJ plant.1 The growth project is intended to help tackle what the CDMO is describing as a need for “high-quality viral vector production.”

The state-of-the-art Hopewell facility was opened in late June, and is considered the company’s flagship CGT center of excellence.² Its design is meant to accommodate end-to-end AAV manufacturing processes that meet both global regulatory and quality standards. The company’s latest services are expected to provide clients with a streamlined experience of its services, including AAV vector manufacturing and GMP plasmid DNA production, along with final drug product formulation and aseptic fill-finish.

Leadership underscores mission to support innovators

By doing so, these efforts are expected to streamline coordination, minimize handoffs, and shorten timelines throughout the drug development lifecycle.

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

The Hopewell staff has decades of practical expertise in biologics and viral vector manufacturing, along with a history of advancing approved therapies from development to commercialization.

"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," commented 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."

Scalable, phase-appropriate manufacturing capabilities

ProBio’s GMP AAV manufacturing services include phase-appropriate production consisting of batch sizes from 50L to 200L, with the capability of concurrent 2x200L runs to support programs from early clinical to late-stage. The fully integrated, single-site platform addresses AAV vector manufacturing, plasmid production, and fill-finish.

The company reportedly sources its raw materials domestically, allowing for a boost in supply chain resilience, faster lead times, and steady quality. ProBio also offers in-house quality control and analytics services, allowing for quicker timelines.

Advanced quality management and regulatory alignment

On the operations and compliance front, the CDMO is utilizing a completely electronic Veeva quality management system (QMS). This type of system support the real-time electronic approval and traceability of GMP documentation, such as deviations, batch records, CAPA events, and change controls.

"What differentiates our AAV platform is the combination of flexible manufacturing architecture and built-in quality by design," said Lance Marquardt, ProBio’s director of AAV manufacturing operations. "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."

Facility opening boosts local economy and supports global expansion

The state-of-the-art Hopewell facility was opened in late June, and is considered the company’s flagship CGT center of excellence, opening up over 110 highly-skilled jobs to the state of New Jersey in the process.²

"Opening the Hopewell center is a milestone in ProBio's global expansion and underscores our mission to support biopharma innovators with high-quality, responsive manufacturing solutions,” Guo mentioned at the time of the facility’s ribbon-cutting ceremony.

References

1. ProBio Launches GMP AAV Manufacturing Services at Hopewell Facility to Advance Gene Therapy Development and Manufacturing. PR Newswire. August 11, 2025. Accessed August 11, 2025. https://www.prnewswire.com/news-releases/probio-launches-gmp-aav-manufacturing-services-at-hopewell-facility-to-advance-gene-therapy-development-and-manufacturing-302526238.html

2. ProBio Opens Flagship U.S. Plasmid & Viral Vector Manufacturing Facility in Hopewell, New Jersey to Advance Cell and Gene Therapy. PR Newswire. June 27, 2025. Accessed August 11, 2025. https://www.prnewswire.com/news-releases/probio-opens-flagship-us-plasmid--viral-vector-manufacturing-facility-in-hopewell-new-jersey-to-advance-cell-and-gene-therapy-302493024.html