Charles River Establishes eXpDNA™ Plasmid Manufacturing Platform to Expedite DNA Programs

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its eXpDNA™ plasmid platform, established from the Company’s contract development and manufacturing (CDMO) and biologics testing experience. The platform significantly reduces plasmid development and production timelines while streamlining the development journey for cell and gene therapy and vaccine developers with a focus on product quality and consistency.

The platform leverages Charles River’s expertise in developing, manufacturing, and releasing more than 200 High Quality (HQ) and Good Manufacturing Practice- (GMP) compliant plasmid DNA batches. eXpDNA supports a client’s plasmid DNA strategy by offering a proven, and standardized plasmid platform approach, suitable for plasmid DNA programs across various applications. The platform consists of an efficient and robust a plug-n-play screening toolbox for tackling challenging plasmids, phase-appropriate production with fit-for-purpose facilities, on-hand materials, and in-house analytics. The standardized process approach expedites batch turnaround times to five weeks for HQ plasmid and 10 weeks for GMP plasmid.

Committed to supporting a large array of advanced therapy clients this universal platform has been adopted successfully for multiple plasmid-based cell and gene therapeutics and vaccines, accommodating various plasmid types.

Phacilitate Advanced Therapies Week

Charles River will officially launch the eXpDNA platform during Phacilitate Advanced Therapies Week, happening January 17 – 20, 2023 at the Miami Beach Convention Center in Miami, FL.

Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services will present:

• eXpDNA Plasmid Platform: Expediting pDNA Production and Supply – January 18, 4:20 – 4:35pm ET.

Matthew Hewitt, PhD, Executive Director Scientific Services, Cell & Gene Therapy, will also participate in:

• Early Adoption and Partnerships: The Secret to Commercialization Success? – January 18, 12:30 – 1:30pm ET (Lunch and Learn).
• The Next Wave: Cell and Gene Therapy's Commercial Shift – January 19, 3:30 – 5:00pm ET (Manufacturing Track).

Dr. Hewitt will chair this cell and gene therapy manufacturing session including program case studies from special guests, including Robert Keefe, Chief Development Officer, BlueSphere Bio.

Join Charles River at Booth #504 during Advanced Therapies Week to discuss cell and gene therapy program requirements with industry leading subject matter experts. To request a meeting, visit criver.com.

Plasmid DNA CDMO Services

Expanding its comprehensive cell and gene therapy portfolio to span plasmid DNA, viral vector, and cell therapy production, through the acquisitions of Cobra Biologics, Vigene Biosciences, and Cognate BioServices in 2021, and in addition to recent expansion projects, Charles River offers end-to-end support and supply chain simplification for developers seeking to accelerate their program whilst ensuring the highest quality control.

The eXpDNA plasmid manufacturing platform builds on Charles River’s established plasmid DNA CDMO capabilities and processes, fine-tuned over decades successfully supporting vaccine and advanced therapy clients through clinical trials and beyond.

For more information, register for Charles River’s upcoming webinar:

• Sustainable Plasmid DNA Strategies: Achieving Streamlined, Secured Supply to Clinic and Commercialization, presented by Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO Services.

Or watch, Navigating Industry Challenges to Drive Sustainable Plasmid DNA Strategies, also presented by Frazer, on demand.

Approved Quotes

• “The launch of Charles River’s eXpDNA plasmid manufacturing platform is the latest in a series of portfolio enhancements aimed at supporting vaccine and advanced therapy clients through clinical trials and beyond. By increasing speed and efficiency for plasmid DNA production, eXpDNA will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster.” – Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River
• “eXpDNA is at the nucleus of our plasmid production offering. The significant turnaround time reduction for clients leveraging the platform, combined with Charles River’s established CDMO capabilities and phase-appropriate approach, will help to both accelerate timelines and ensure the highest quality product.”– Andrew Frazer, PhD, Associate Director, Scientific Solutions, 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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