Charles River Launches Viral Vector Reference Materials to Streamline the Transition to GMP

Supporting scale-up for early-phase AAV- and LVV-based gene and gene-modified cell therapy researchers and developers

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its reference materials for adeno associated virus (AAV) and lentiviral vector (LVV) portfolio, designed to streamline Cell and Gene Therapy (CGT) research and development as it scales to Good Manufacturing Practice- (GMP) quality.

Moving towards a gold standard for reference materials, Charles River is introducing six AAV reference material serotypes, offering superior empty and full capsid ratios and high vector genome concentration (GC/mL), plus five LVV reference material products, available with different combinations of promoters and reporter genes. The additional reference materials add to the Company’s extensive portfolio of plasmid and viral vector contract development and manufacturing organization (CDMO) offerings, reinforcing its concept-to-cure commitment to CGT researchers and developers by enabling partners to navigate the path from early discovery to commercial.

ASGCT Launch

Charles River will officially launch its AAV and LVV reference materials with supporting case study data during the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, May 7 – 11, 2024, in Baltimore, MD.

Meet the Charles River team at Booth #327 to discuss how to streamline the CGT research and development process, and explore various presentations and scientific posters from subject matter experts, including:

• A cross-functional research and discovery project showcasing AAV reference material data, AAV Cell Surface Target Profiling Using Binding and Functional Cell Microarray Screening Technology (#462), presented by Claire Tebbutt, Group Leader, Discovery
  • Wednesday, May 8, 12:00-7:00 p.m.: AAV Vectors – Virology and Vectorology (Exhibit Hall)
• Closed Automation Enables Quick Fill-Finish of Large-Scale T Cell Therapy While Maintaining Consistency and Quality of the Final Product (#867), presented by Min Sung Park, Process Development Scientist, Cell and Gene Therapy CDMO Services
  • Wednesday, May 8, 12:00-7:00 p.m.: Cell Therapy Product Engineering, Development, and Manufacturing (Exhibit Hall)
• Matrix Approach for Potency Assay Development of Cell and Gene Therapy Products: A Case Study for AAV Vectors (#1519), presented by Karen Doucette, Scientific Advisor, Cell and Gene Therapy CDMO Services
  • Friday, May 10, 12:00-7:00 p.m.: AAV Vectors - Product Development Manufacturing and Approval Considerations (Exhibit Hall)

To view the full list and to schedule a meeting, visit criver.com.

Cell and Gene Therapy CDMO Solutions

With a strong track record supporting multiple client programs, Charles River’s viral vector CDMO center of excellence in Rockville, MD, offers integrated solutions to support CGT programs from pre-clinical research to commercial scale.

To learn more about Charles River’s CGT portfolio and gain real-world insights from a development, manufacturing, and testing perspective, join an expert roundtable webinar hosted by Human Gene Therapy, Streamlining Cell and Gene Therapy Scalability: Progress Towards a Gold Standard, moderated by James Cody, PhD, Associate Director, Technical Evaluations on May 13, 2024.

To learn more about optimizing the development of gene therapy products, join the upcoming Charles River webinar, The Roadmap to Fast-Tracking Gene Therapy Development, on June 4, 2024. The multi-disciplinary panel will explore in vitro approaches to optimize and support the development of gene therapy products, including key considerations and real-world data highlighting routes to de-risk your therapeutic product.

Approved Quotes

• “This expansion of the CGT product portfolio empowers our partners to navigate the path from research to commercialization under one organization, providing a streamlined process. Combined with Charles River’s established CDMO capabilities, this enables us to continue to work towards our ultimate goal of delivering safe, effective therapies to patients faster.” – Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River
• “The launch of Charles River’s AAV and LVV reference materials portfolio is the latest in a series of enhancements in our CDMO products and services offerings. We look forward to showcasing our robust portfolio and supporting data during the ASGCT Annual Meeting.” – Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, Charles River

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

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