Charles River Launches nAAVigation Vector Platform to Accelerate Gene Therapy Programs
October 10, 2022 – Drug Discovery –
WILMINGTON, Mass.–(BUSINESS WIRE)–Oct. 10, 2022– Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its nAAVigation™ Vector Platform (nAAVigation). Leveraging decades of Adeno-Associated Virus (AAV) vector contract development and manufacturing (CDMO) experience and biologics testing expertise, Charles River has established a platform which streamlines the pathway to GMP AAV vector manufacturing without the need for significant process development. The nAAVigation platform has the capability to reduce a programís timeline to GMP for viral vector gene therapy developers by 55 percent, translating to fewer than eight (8) months compared to traditional manufacturing workflows.
Charles Riverís nAAVigation approach is based on a proprietary high-productivity HEK293 suspension cell line, which is amenable to clientsí scale-up and serotype needs. nAAVigation utilizes an optimized single-use upstream approach coupled with robust downstream purification processes, enabling client AAV programs to scale up to 500L in suspension. The nAAVigation platform accelerates time to clinic by leveraging established development processes, on-hand materials, templated documents, and 100 percent qualified, in-house analytics.
Meeting on the Mesa
Charles River will launch the nAAVigation platform approach and will highlight its benefits during a reception on October 12, during Cell and Gene Meeting on the Mesa, in Carlsbad, CA.
Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services will present at the Reception in the Command Post Meeting Room:
- nAAVigationTM Vector Platform: Accelerating Your AAV Pathway to GMP and Clinic – Wednesday, October 12, 5:00pm – 8:00 pm PST
In addition, Nicholas Ostrout, PhD, Senior Advisor, Cell and Gene Therapy Corporate Strategy, will present in Aviara Salon A:
- The Future of CDMO Networks in Cell and Gene Therapy – Wednesday, October 12, 7:45am – 8:45am PST
Daniel Smith, PhD, Executive Director, Global Cell and Gene Therapy Portfolio will present in UBC Ballroom:
- New Business Models for Manufacturing Investment – Wednesday, October 12, 3:15pm – 4:15pm PST
Join Charles River for three days of partnering and industry updates on clinical trial design, alternative payment models, scale-up and supply chain platforms for advanced therapies, and more.
Viral Vector CDMO Services
With over 20 years of viral vector CDMO expertise and a validated platform process with a proven track record, Charles River has standardized protocols for cell culture, transfection, and downstream purification. These high-yield, optimized methods increase speed to clinical manufacturing by reducing process development time and costs while ensuring the highest quality production.
nAAVigation builds on Charles Riverís industry-leading viral vector CDMO capabilities with established processes for AAV production and purification, and testing expertise.
Expanding its comprehensive cell and gene therapy portfolio to span viral vector, plasmid DNA, and cell therapy production, through the acquisitions of Vigene Biosciences, Cobra Biologics, and Cognate Bioservices in 2021, the Company offers end-to-end support and supply chain simplification for advanced therapy (ATMP) developers.
‘The launch of the nAAVigation Vector Platform process is the latest in a series of portfolio enhancements aimed at supporting our cell and gene therapy clients from early target identification through clinical-stage manufacturing. By increasing speed and efficiency for viral vector production, nAAVigation will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster.’ – Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River
‘The significant turnaround time reduction for viral vector therapy developers utilizing nAAVigation combined with Charles Riverís established development process, standard, on-hand materials, templated documents, and in-house analytics will enhance our clientsí experiences.’- Professor Daniel Smith, Executive Director Global Cell and Gene Therapy Portfolio, Charles River
