Hear from Our Manufacturing and Testing Experts: An Extension of Your Team
Viral Vector CDMO Center of Excellence
Our viral vector contract development and manufacturing (CDMO) center of excellence, located in Rockville, MD, is designed to support cell and gene therapy programs through a range of research-grade products and GMP-compliant clinical to commercial manufacturing.
Bolstered by a strong culture of quality, the team recognizes the purpose of our mission: supporting clients through the development of life-changing therapies, our people, our performance, and our portfolio.
Fully integrated within a concept to cure portfolio from discovery services through commercial manufacturing, the Rockville team works closely with our plasmid DNA center of excellence in Keele, UK, providing fit-for-purpose starting materials, and our Memphis, TN, cell therapy CDMO facility for onward development, with 100% in-house testing to streamline client programs.
With eight production suites, the facility has established manufacturing platforms and supports a diverse range of advanced therapeutics, specializing in the GMP manufacture of adeno-associated virus (AAV), lentivirus, adenovirus, and retrovirus.
Right on time, the first time: the site is proud of its impressive manufacturing success rates and 100% on-time scheduling, because every moment matters on the path to clinic.
Cell Therapy CDMO Center of Excellence
With 25 GMP-ready suites, all FDA and EU ATMP compliant, the Memphis, TN CDMO Center of Excellence is Charles River’s premier manufacturing hub for cell and gene-modified cell therapies.
Through strategic investments in state-of-the-art facilities and the latest CGT platforms, the site has a proven track record of accelerating development timelines and streamlining manufacturing processes through commercialization.
Our dedicated team of highly skilled professionals can facilitate scale-up and scale-out methods for both autologous and allogeneic cell therapies from early through late-phase, including quality control release testing on-site. In fact, the GMP-ready suites offer the flexibility to transition from clinical to commercialization all under one roof.
Most recently, the Memphis site was upgraded with an improved quality management system (QMS) that is expected to exceed regulatory requirements during future inspections by global health organizations.
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, allowing for commercial production across the US, Europe, and Canada.
Biologics Testing CRO Center of Excellence
At Erkrath, our scientists, quality specialists, and project management teams work together to bring deep technical expertise, regulatory understanding, and client focus to every program. This recently expanded site offers GMP-compliant services for analytical testing of biologic products, including validation of test methods for cell line characterization (human, animal, and microbial), raw material testing, bulk harvest testing, and lot release and stability testing.
The Erkrath facility specializes in biologics safety testing for monoclonal antibodies, recombinant proteins, and advanced therapies. With rapid turnaround times and global harmonization, we prioritize quality and regulatory compliance at every step. The site includes BSL2 laboratories, strict adherence to Good Manufacturing Practice (GMP) requirements, and compliance with the FDA and EMA, ensuring quality controls.
We partner with our clients to tailor testing strategies to their molecules, timelines, and regulatory needs. Whether supporting method development or rapid lot release, our team anticipates challenges so clients don’t face delays.
As part of Charles River’s global biologics testing network, Erkrath ensures seamless method transfer, integrated data flow, and consistent quality, regardless of where your therapy is tested.
Manufacturing Leadership Team
Produced in collaboration with The Medicine Maker, join Kerstin Dolph to learn how the team navigates manufacturing excellence to help clients move from concept to cure, Ahmad Hussin on how our CDMO operations are designed for agility and integration, and David Russell shares how we can help bring your therapy to market, faster.
GMP-compliant products released
Biologics tests conducted each year
Dedicated testing and manufacturing facilities
Years of CRO and CDMO expertise
Tap into a global network of integrated development, manufacturing, and testing centers of excellence to streamline your program.
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