The platform can reduce lentiviral vector production timelines from 18 months to less than 7 months

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its lentiviral vector (LVV) manufacturing platform, Lentivation™. The platform has the capability to reduce LVV manufacturing timelines for gene and gene-modified cell therapies by up to 60 percent, translating to fewer than seven months compared to traditional manufacturing workflows.

Charles River provides viral vector production services ranging from clone construction through good manufacturing practice (GMP) for clinical trials or commercial use and offers a dedicated portfolio to meet customer specific needs such as regulatory requirements or product characteristics, with stringent, in-house quality control adhering to the highest standards of purity and potency.

Meeting growing client needs for clinical and commercial supply, Lentivation leverages Charles River’s robust screening toolbox for tackling challenging gene-of-interest plasmids, off-the-shelf (OTS) LVV packaging plasmids, phase-appropriate production with fit-for-purpose facilities, on-hand materials, and in-house analytics.

Gene Therapy CDMO Services

With over 20 years of viral vector contract development and manufacturing organization (CDMO) expertise and validated platform processes 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 high quality production.

The addition of Lentivation follows the launch of Charles River’s OTS LVV packaging and AAV pHelper plasmids, and eXpDNA™ plasmid manufacturing platform, aimed at supporting both LVV-based and AAV-based gene therapy programs. Lentivation also complements the nAAVigation™ platform announced previously, further bolstering Charles River’s cell and gene therapy manufacturing capabilities.

These offerings have been established over decades of plasmid DNA and viral vector CDMO scale-up experience which, combined with the Company’s in-house testing capabilities, significantly reduces production turnaround time for advanced therapy medicinal product (ATMP) and vaccine developers.

The Lentivation platform will be presented during the BioInsight’s Expert Roundtable: Exploring current and future trends in lentiviral vector manufacturing featuring Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services on September 27, 2023, at 11:00 am EDT.

Approved Quotes

• “We are thrilled to add the Lentivation platform to our robust portfolio of existing capabilities. Our LVV manufacturing offerings allow us to further support advanced therapy programs and, most importantly, deliver novel gene therapies to patients across the globe." - Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River
• “Charles River’s LVV platform provides a streamlined, reliable path for therapeutic developers to clinic and commercial. The proven platform builds on Charles River’s established capabilities and processes, fine-tuned over decades spent successfully supporting advanced therapy clients.” - Beth Tebeau, Site Director, Rockville, MD, 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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