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Most biopharma companies depend on a contract development and manufacturing organization (CDMO) for some steps—often all steps—in the production of material for clinical trials and manufacturing therapies. In late 2023, however, Gil Roth, president of the Pharma & Biopharma Outsourcing Association, wrote: “The last several years have been tumultuous for the CDMO sector.”1 Nonetheless, this sector continues to play a vital role in supplying customers with new and long-standing treatments, and many biopharma companies need to partner with an experienced and reliable CDMO.
Charles River Laboratories—founded in 1947 and headquartered in Wilmington, MA, just west of Boston—is a veteran contact research organization (CRO) and CDMO that supports clients from drug discovery and development through commercialization. In addition to conducting more than 1,000 studies in cell and gene therapies, including supporting the development of 20 of those approved by the FDA, the company constantly develops new tools and technologies to accelerate, improve, and scale the development of drug therapies.
Tools for Testing
The development and manufacturing of cell or gene therapies requires safety and efficacy testing. The latest in its portfolio, Charles River developed reference materials for
adeno-associated viruses (AAV) and lentiviral vectors (LVV), including six AAV stereotypes and five LVV products.
As Elizabeth Misleh, associate director, gene therapy research solutions, Charles River, says, “Our AAV reference materials boast superior empty/full capsid ratios and high vector concentrations, while our LVV reference material comes in various combinations of promoter and reporter genes.”
These reference materials can be used from early discovery through manufacturing as controls for assay development and validation. “Some of the assays include, but are not limited to, infectivity testing, transduction efficiency, biodistribution studies, and standard in-process testing,” Misleh explains.
Transferring Viral Vectors
Building on established viral vector production platforms—nAAVigation™ and Lentivation™, which streamline AAV- and LVV-based programs, respectively—Charles River launched a new framework for technology transfer of viral vectors at BIO 2024. “It’s a methodical approach to transfer products from one facility into ours in the most expedited way,” says Ramin Baghirzade, PhD, senior director, global head commercial, gene therapy CDMO services, Charles River.
With more than 20 years’ experience with tech transfers from drug manufacturers and other CDMOs, this program includes fast-track and modular frameworks. “Within the fast-track framework, we’re taking a product as is and transferring it, because the process is robust and no changes are required before taking it to GMP,” Baghirzade says. “With the modular approach, our partners can customize the technology transfer by selecting modules, such as plasmid supply and process development, to suit their program.” Either way, technology transfer of viral vectors facilitates program continuity and de-risks supply chains.
Cell Therapy Flex Platform
In May, Charles River reinforced its commitment to cell and gene therapy developers in launching its Flex Platform for CAR T and TCR T cells. The Flex Platform is “an off-the-shelf solution for people who need to make these cell therapies,” says Alex Sargent, PhD, director of process development, Charles River. “It’s designed to be a modular approach, and it allows for maximum flexibility so it suits a wide variety of processes.”
In addition to being flexible, this platform includes other key attributes: automation, artificial intelligence (AI), and GMP operations. “These fully automated solutions are AI-enabled and functionally closed technologies that deliver a process adapted for GMP operations,” Sargent says. “The Flex Platform can significantly shorten development times and get cell therapy products into clinical production faster.”
Along with the Flex Platform, Charles River’s tools for viral vectors, including reference materials and technology transfer, accelerate the development of new gene-modified cell therapies, which is one of the fastest growing segments across all cell- and gene-based treatments.
Reference
1. Roth, G. The road ahead for CDMOs in 2024. Contract Pharma. 2023.
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