ProBio, a prominent contract development and manufacturing organization (CDMO) renowned for its expertise in gene and cell therapy, has officially launched its cGMP Adeno-Associated Virus (AAV) manufacturing services at its expansive 128,000 sq. ft. facility in Hopewell, New Jersey. This strategic move aims to address the increasing demand within the industry for high-quality viral vector production and underscores ProBio's dedication to advancing transformative gene therapies.

The facility is staffed by industry-leading specialists who work collaboratively in cutting-edge manufacturing suites, merging extensive scientific knowledge with operational excellence to provide high-quality, end-to-end GMP AAV solutions. Their profound experience in advanced biologics manufacturing guarantees precision, efficiency, and unwavering adherence to global regulatory and quality standards, which is crucial for the successful progression of next-generation gene therapy initiatives.

Equipped with an advanced upstream manufacturing suite featuring state-of-the-art single-use bioreactor systems, ProBio's Hopewell facility can handle production capacities of up to 2x200L for concurrent runs. This design enables scalable GMP AAV manufacturing solutions tailored to the needs of both clinical and commercial gene therapy programs, ensuring flexibility, efficiency, and compliance with global quality standards.

The facility is specifically designed to provide comprehensive AAV manufacturing solutions that align with global regulatory and quality norms. ProBio's enhanced capabilities deliver clients a fully integrated service platform that includes GMP plasmid DNA production, AAV vector manufacturing, and final drug product formulation and aseptic fill/finish—all from a single U.S.-based location. This streamlined process minimizes coordination challenges, reduces handoffs, and accelerates timelines throughout the drug development lifecycle.

"At ProBio, we recognize that every gene therapy program represents a critical opportunity to change lives," stated 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 team at Hopewell brings decades of practical experience in biologics and viral vector manufacturing, having supported 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," mentioned 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."

Key features of ProBio's GMP AAV manufacturing services include:

- Scalable, Phase-Appropriate Manufacturing: Offering flexible batch sizes from 50L to 200L, with the capability for 2x200L concurrent runs—supporting early clinical to late-phase programs.
- Fully Integrated Platform, Single-Site Solutions: Providing high-quality plasmid production, AAV vector manufacturing, and final drug product fill/finish all under one roof—simplifying the process, saving time, and accelerating the developer’s path to the clinic.
- Resilient U.S.-Based Supply Chain: By focusing on domestic sourcing for key raw materials, ProBio ensures greater supply stability, faster lead times, and consistent quality—allowing gene therapy developers to proceed with confidence.
- Accelerated Timelines Through In-House Analytics: Comprehensive internal QC and analytical capabilities enable rapid, phase-appropriate release while upholding the highest standards of precision and compliance.

To improve operational efficiency and guarantee seamless compliance, ProBio has adopted digitalization by implementing a fully electronic Quality Management System (QMS) powered by Veeva. This system facilitates real-time electronic approval and traceability of critical GMP documentation, including batch records, deviations, change controls, and CAPA events—bolstering both regulatory alignment and operational speed.

"What differentiates our AAV platform is the combination of flexible manufacturing architecture and built-in quality by design," remarked 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."

With this launch, ProBio solidifies its position as a strategic partner for gene therapy innovators, offering agile, phase-appropriate manufacturing solutions that adapt to the evolving needs of each program.