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In the development of DNA vaccines and cell and gene therapies, manufacturing plasmid DNA creates a crucial bottleneck. Such a slowdown could intensify with the market for manufacturing DNA plasmids expected to grow at nearly 14% a year through 2030, when it reaches $1.5 billion. To help meet that demand, Charles River is investing into its two dedicated plasmid contract development and manufacturing (CDMO) facilities and has established the eXpDNA™ plasmid platform to accelerate timelines without compromising on quality.
The company started producing a range of plasmid products at its Keele site more than 20 years ago, and now this facility focuses on GMP-grade plasmid manufacturing. In 2022, the company also opened a second plasmid manufacturing site at Alderley Park with the capacity to produce >120 batches of High Quality (HQ) plasmid DNA per year to support early stage clinical and GMP viral vector applications. As Andrew Frazer, PhD, associate director scientific solutions, cell and gene therapy at Charles River, points out: “The establishment of these dedicated centers of excellence represents a significant increase in production capacity but also the opportunity to realize a range of operational efficiencies to support our service offerings.”
With HQ- and GMP-plasmid production capabilities, Charles River can meet the needs of a wide range of customers throughout the therapeutic development and commercialization pathway.
Building a better plasmid platform
The eXpDNA platform is an advancement from Charles River’s long history of developing, manufacturing, and releasing plasmid DNA batches at various levels of quality and scale. “The platform utilizes a fully single-use manufacturing process stream,” Frazer says. “This supports rapid turnaround, improved suite utilization and effective control of cross-contamination within the multi-product facilities.” When combined with fully in-house analytical testing, Charles River can now produce HQ plasmid DNA in as little as five weeks or GMP-grade plasmids in as few as 10 weeks.
Speed, though, does not come ahead of quality. By using a universal and standardized plasmid-platform approach, eXpDNA works with all common plasmid DNA programs. Plus, this platform’s plug-and-play screening toolbox optimizes production and simplifies the transition from HQ- to GMP-grade manufacturing—all with predictable scale-up and advanced quality control to ensure optimum quality plasmids without cross-contamination.
Leveraging a legacy
Undoubtedly, Charles Rivers leverages its decades of experience. Expanding a comprehensive cell and gene therapy portfolio to span plasmid DNA, viral vector, and cell therapy production, through the acquisitions of Cobra Biologics, Cognate BioServices, and Vigene Biosciences in 2021, the company offers end-to-end support and supply chain simplification for developers seeking to accelerate their program whilst ensuring the highest quality control. “For more than 20 years, we’ve worked with a huge number of different plasmid programs, including lots of challenging plasmids, and we have a standardized toolbox approach to tackle these,” Frazer explains. “ We have an efficient and robust process in place that helps manage difficult sequences and mitigate risk for our customers.” Consequently, he says, “This ensures that we don’t have any surprises when we get to the manufacturing stage.”
The eXpDNA platform covers manufacture and testing of both HQ and GMP grade cell banks using an in-house, royalty free host cell line or, for customers with good quality cell banks, Charles River can start with that. “There are lots of different levels of optimization and development we can do depending on what the customer needs,” Frazer says. “The vast majority of people want a quick and reliable turnaround without compromising on quality —right the first time—so that they can then plan ahead on subsequent manufacturing steps and/or clinical trial milestones within their program.”
Creating a complete solution
Charles River accelerates the production of the world’s growing collection of plasmid-based advanced therapies and vaccines. The company accomplishes that with an integrated development, manufacturing, and testing solution that includes scientific, regulatory, technical, and logistics expertise—all under one roof.
In addition to working with clients on custom solutions, Charles River is developing pre-made, off-the-shelf plasmid products for applications in common viral-vector manufacturing. Launching in Q1 2023, these off-the-shelf products will enhance and compliment the eXpDNA service offering and deliver additional time and cost benefits for viral vector based advanced therapy applications.
Given the life-saving benefits of vaccines and advanced therapies, Frazer says that “manufacturers and developers need to figure out how to make these therapies more cost effectively and reduce timelines, while still maintaining a focus on quality.” He adds, “Charles River’s eXpDNA platform provides a range of solutions for common plasmid supply challenges and when combined with our capability in cell and gene therapy and biologics testing we have the ability to improve the delivery of plasmid products, associated advanced therapies and, ultimately, medicines to patients.”
For more information on Charles River’s phase-appropriate plasmid CDMO solutions, visit: criver.com/plasmid