ProBio Launches End-to-End AAV Production at NJ Manufacturing Site

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ProBio, a contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, announced on Aug. 11, 2025 the launch of current good manufacturing practice (CGMP) adeno-associated virus (AAV) manufacturing services at its 128,000-sq.-ft. facility in Hopewell, N.J. The launch comes as demand for high-quality viral vectors continues to grow alongside an expanding pipeline of gene therapies.

The Hopewell site was designed to provide end-to-end AAV manufacturing capabilities that align with global regulatory and quality requirements. Services at the facility include GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation with aseptic fill and finish. By consolidating these steps within one US-based location, the approach is intended to reduce process complexity, minimize production handoffs, and shorten development timelines.

"At ProBio, we recognize that every gene therapy program represents a critical opportunity to change lives," said Allen Guo, chief executive officer of ProBio, in a company press release (1). "Our new GMP AAV manufacturing platform reflects our mission to help developers navigate complex manufacturing challenges with speed, precision, and scientific integrity."

Integrated manufacturing, flexible scale, and digital quality systems

The facility supports scalable, phase-appropriate manufacturing with batch sizes ranging from 50 L to 200 L and has the capability to run two 200-L batches concurrently. This capacity allows the facility to handle programs ranging from early clinical development to late-phase supply.

Supply chain resilience has also been factored into the design, with a focus on sourcing critical raw materials domestically. This measure can help reduce lead times and protect against shortages that could delay clinical or commercial milestones.

In addition, analytical testing and quality control operations are performed in-house to accelerate product release while maintaining compliance. The facility’s quality oversight is supported by a fully electronic quality management system powered by Veeva, according to the company. This system enables real-time electronic approval and traceability for GMP documentation such as batch records, deviations, change controls, and corrective and preventive actions, thus combining regulatory compliance with operational efficiency.

"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, in the release. "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."

Adding significant domestic capacity

"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, in the release. "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."

For the cell and gene therapy sector, this launch adds significant domestic capacity for a critical component of gene therapy production. By integrating scalable manufacturing, advanced quality systems, and a single-site approach, the Hopewell facility reflects broader industry trends toward more agile and compliant manufacturing models to keep pace with rapidly evolving therapeutic pipelines (2,3).

References

1. ProBio. ProBio Launches GMP AAV Manufacturing Services at Hopewell Facility to Advance Gene Therapy Development and Manufacturing. Press Release. Aug. 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. Algorri, M.; Abernathy, M.J.; Cauchon, N. S.; et al. Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access. J. Pharm. Sci. 2022, 111 (3), 593–607. DOI: 10.1016/j.xphs.2021.08.032.
3. Battelle Insider. The Road to Agile Pharmaceutical Manufacturing. inside.battelle.org, June 2, 2025. https://inside.battelle.org/blog-details/the-road-to-agile-pharmaceutical-manufacturing