Featured News
Milestone in Global Regulatory Compliance
Memphis CDMO Site Clears Global Health Inspection Audits
Completing a major milestone in global regulatory compliance, our CDMO Center of Excellence in Memphis, TN, recently cleared back-to-back inspections by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
The regulatory inspections were completed in July and October, respectively, affirming the Memphis site operates according to Good Manufacturing Practice (GMP) and Quality Management System (QMS) requirements necessary to ensure patient safety and product quality for our clients and the patients they serve.
Future-Proof Your CGT Manufacturing
In 2022, Memphis became the first North American CDMO site to earn approval from the EMA to commercially produce an allogeneic cell therapy drug product. These recent successful outcomes demonstrate Charles River's commitment to providing robust quality and manufacturing services for cell and gene-modified cell therapies. They also reflect our capability to meet global regulatory standards for these modalities by offering phase-appropriate, agile systems for both clinical and commercial drug products.
Ellyn Torosian, Executive Director, Global Head of CDMO Quality, noted, "Clients in the cell and gene-modified cell therapy space greatly benefit from a CDMO that offers expertise and agility in quality. With our quality capabilities and client-centric approach, we partner with our clients to thoroughly understand their processes and potential risk points."
She added, "Our approach of building quality by design into everything we do allows us to provide manufacturing solutions that reduce risk and accelerate our clients' therapies to clinic and commercialization."
Regulatory and Process Strategies for CGT Drug Products
To successfully bring a new cell or gene therapy to market, developers must integrate regulatory compliance and process optimization through the entire drug product lifecycle. Hear from experts on how to prepare for IND and BLA submissions.
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Raising the Bar on CDMO Quality Standards
Early in 2025, the Memphis site completed upgrades to the facility as well as to the site contamination control strategy (CCS) and the QMS.
The improvements expanded training, cleanroom behaviors, and aseptic techniques for sterility assurance of products. The enhancements to the QMS were driving factors in the recent successful inspections, but also aligned with our mission to enable visibility, speed, and collaboration with our clients by delivering high-quality standards and accelerated delivery of drug products.
The Memphis site has completed successful GMP compliance inspections with the FDA’s CBER and Center for Drug Evaluation and Research (CDER), Health Canada, and numerous national authorities in European Union (EU) member states that comprise the EMA.
As part of our mission to raise the bar for delivering the highest quality standards in the industry, we continue to pursue opportunities to outpace the regulatory landscape in our quality and compliance offerings and expand support for our clients in their clinical and commercial marketing endeavors.
With this, along with our end-to-end CDMO capabilities, including leading-edge cell therapy manufacturing services, onsite testing, and Chemistry, Manufacturing, and Controls (CMC) authoring and review, we aim to build upon the 3 Biologic License Application (BLA) submissions and 10 Investigational New Drug (IND) applications for novel cell therapies that we’ve supported.