New plasmids will help accelerate and standardize lentiviral vector development from clinical to commercial manufacturing

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its off-the-shelf lentiviral vector (LVV) packaging plasmids, providing a streamlined solution to the challenges associated with plasmid sourcing in cell and gene therapies.

Cell and gene therapies often rely on plasmid DNA (pDNA) as a critical starting material. However, production challenges such as capacity bottlenecks and timeline pressures, as well as a need for process development optimization can result in increased lead time, cost and complexity. Charles River’s off-the-shelf packaging plasmids offer an alternative solution to these hurdles with immediate availability, reduced development costs and simplified supply chains that streamline and secure lentiviral vector production.

In addition to its off-the-shelf offerings, Charles River provides services to meet customer specific needs such as regulatory requirements or product characteristics. These include viral vector production services ranging from clone construction through good manufacturing practice (GMP) for clinical trials or commercial use.

Plasmid DNA CDMO Services

The addition of off-the-shelf LVV plasmids follows the launch of Charles River’s pHelper plasmids aimed at supporting AAV based gene therapy programs and eXpDNA™ plasmid manufacturing platform, established over decades of plasmid DNA CDMO scale-up experience which significantly reduces plasmid production turnaround time for advanced therapy medical product (ATMP) and vaccine developers.

In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisitions and recent expansions to simplify complex supply chains and meet growing global demand for plasmid DNA, viral vector, and cell therapy services. The Company offers end-to-end support and supply chain simplification for cell and gene therapy developers. Combined with the Company’s legacy testing services, Charles River offers an industry-leading “concept-to-cure” solution for advanced therapies.

Approved Quotes

• “We are thrilled to announce this addition to our product offering. Our LVV packaging plasmids allow us to further support advanced therapy programs and most importantly, help expedite the delivery of safe, effective therapies to those who need them most." - Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions
• “Charles River’s LVV packaging plasmids offer researchers and manufacturers a high-quality, reliable tool to support their LVV viral vectors production. The new plasmids will be a valuable resource to develop new treatments for a wide range of programs in preclinical and clinical development with the continuity of supply for commercial use” - Andrew Frazer, Associate Director, Scientific Solutions

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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