#USA #gene therapy #ProBio #Hopewell #AAV Manufacturing

ProBio Launches GMP AAV Manufacturing Services at Hopewell Facility

ProBio, a renowned name in the realm of contract development and manufacturing organizations (CDMO), has recently announced the launch of its GMP (Good Manufacturing Practice) AAV (Adeno-Associated Virus) manufacturing services at its expansive 128,000 sq. ft. facility located in Hopewell, New Jersey. This initiative is aimed at fulfilling the rising demand for superior quality viral vector production and aligns with ProBio's dedication to advancing transformative gene therapies.

In the modern scientific landscape, ProBio stands out due to its commitment to high-quality manufacturing workflows, employing a team of industry-leading specialists who work within cutting-edge manufacturing suites. These professionals combine their extensive scientific expertise with operational excellence to provide comprehensive GMP AAV solutions, ensuring every step meets global regulatory and quality standards. This focus paves the way for the progressive advancement of next-generation gene therapy initiatives.

The state-of-the-art facility features an advanced upstream manufacturing suite, which includes modern single-use bioreactor systems capable of supporting simultaneous production runs of up to 200 liters each, thus providing scalable GMP AAV manufacturing solutions catered to both clinical and commercial gene therapy programs. Such flexibility ensures that ProBio can quickly respond to the varying needs of biotechnology firms, thereby assisting in the efficient and compliant progression of their projects.

Moreover, this facility serves as a comprehensive hub for AAV manufacturing, providing clients with fully integrated services ranging from GMP plasmid DNA production to AAV vector manufacturing, and even the final drug product formulation and aseptic fill/finish. By centralizing these processes in one U.S.-based location, ProBio simplifies project coordination, reduces the number of handoffs, and ultimately speeds up the timelines associated with drug development.

Allen Guo, the CEO of ProBio, emphasized the significance of each gene therapy project, highlighting it as an essential opportunity to make impactful changes in patients' lives. He stated, "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 accumulated experience in the fields of biologics and viral vector manufacturing. Their history of supporting the development and commercialization of successfully approved therapies positions them perfectly to add value to ProBio’s gene therapy initiatives. Michael Vreeland, the U.S. Site Head, echoed this sentiment, noting that the launch of the GMP AAV services is a result of profound cross-functional collaboration within the company.

ProBio's GMP AAV manufacturing services boast several key features:

• - Scalable, Phase-Appropriate Manufacturing: Capable of handling flexible batch sizes ranging from 50 to 200 liters, with provisions for concurrent runs of 200 liters, this capability supports the rigorous demands of early to late-phase gene therapy programs.
• - Fully Integrated Platform, Single-Site Solutions: ProBio ensures a seamless process from plasmid production to final product fill/finish, effectively reducing complexity and significantly accelerating the developer’s journey to clinical trials.
• - Resilient U.S.-Based Supply Chain: By prioritizing the sourcing of key raw materials domestically, ProBio secures a stable supply chain that guarantees speed and consistency, empowering developers as they move forward.
• - Accelerated Timelines Through In-House Analytics: With comprehensive internal QC and analytical capabilities, ProBio facilitates rapid and phase-appropriate release while adhering to high standards of precision and compliance.

To amplify operational efficiency and compliance, ProBio has embraced digital transformation through the implementation of an electronic Quality Management System (QMS) powered by Veeva. This enables real-time electronic approval and traceability of critical GMP documentation, such as batch records, deviations, change controls, and corrective actions, consequently supporting both adherence to regulations and the speed of execution.

"What distinguishes our AAV platform is our flexible manufacturing architecture combined with built-in quality by design," remarks Lance Marquardt, Director of AAV Manufacturing Operations at ProBio. "Our processes are engineered to handle a diverse array of serotypes, production scales, and clinical milestones, all while maintaining tight in-process controls and regulatory alignment at every juncture."

With this substantial enhancement to their service offerings, ProBio is poised to solidify its position as a vital partner for innovators in the gene therapy sector, providing adaptable, phase-appropriate manufacturing solutions designed to evolve alongside the unique demands of each therapeutic program.

About ProBio

ProBio is recognized as a global leader in the evolution of the development and manufacturing of cutting-edge biologics and advanced therapies catering to the biotech and pharmaceutical industries. As a comprehensive end-to-end CDMO, ProBio collaborates with clients to streamline drug development processes, hasten market entry, and deliver extensive life-cycle support. Through a cooperative and risk-sharing approach, ProBio offers adaptable licensing and co-development options for novel therapeutics, enabling collaborators to efficiently address the complexities of human diseases with innovative therapeutic solutions. To explore ProBio's services further, visit ProBio CDMO.