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Enhancing Quality Standards in Memphis
History of GMP Manufacturing Compliance
The Memphis CDMO Center of Excellence for cell and gene-modified cell therapy manufacturing has a history of GMP compliance that stretches back to 2018 with our first commercial allogenic cell therapy product. Since then, the site has manufactured a second commercial autologous cell therapy and distinguished itself as the first North American CDMO to earn approval from the European Medicines Agency (EMA) to commercially produce an allogeneic cell therapy drug product.
Inspections by other health agencies have continued as we’ve expanded our approval for commercial production into additional geographies across the United States, Europe, and Canada. As the regulations surrounding cell and gene therapies continue to evolve, infrastructure, processes, and training standards at the site must be upgraded to meet those requirements and ensure product quality and patient safety.
Recently, the Memphis CDMO site was upgraded to better meet quality standards through an enhanced contamination control strategy (CCS), improved aseptic techniques for sterility assurance, expanded training plans, and a new electronic records management system. These initiatives provide the Memphis CDMO site with a quality management system (QMS) expected to exceed regulatory requirements during future inspections by global health organizations.
Compliance: A Journey and A Destination
We started the QMS enhancements in August 2024 after learning that updates were needed with quality system records and governance documentation. A site-wide QMS transformation ensued with improvements in contamination control monitoring, robustness of standard operating procedures, and utilization of more electronic pathways for QMS management.
This comprehensive overhaul has shown immediate improvement, with open QMS records decreasing by 76% from August 2024 to January 2025 across all CDMO areas. This number is expected to improve as quality standard program overhauls continue to be implemented and the broad application of electronic systems moves forward – both of which bring greater visibility for ensuring timely analysis and completion of work.
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Raising the Bar for Quality Standards
In 2025, the quality standards upgrades have continued, expanding to include manufacturing facility and suite enhancements.
After a scheduled pause in GMP operations for capital improvements and remodeling, which included updating the 10 Riverside Manufacturing Suites to add airlocks, upgrades to locker rooms, and additional transition space for gowning and demarcation lines for better contamination control, the site resumed GMP operations in April.
The Memphis CDMO site now offers clients 25 GMP manufacturing suites, all ISO 7 and FDA 21 CFR 211 / EU ATMP Part IV compliant, with the flexibility to transition from clinical development to commercialization for both cell and gene-modified cell therapies.
With these enhancements in place, site leadership is now working to ensure these quality standard and sterility improvements are not only maintained to the highest degree going forward but also applied to all CDMO facilities globally by 2026 as the new QMS benchmark.