Cell Therapy Commercialization

Moving your cell therapy clinical trial beyond Phase I is an exciting time, marking a significant milestone. There are many therapeutic developers working to address critical patient needs in oncology, auto-immune, regenerative medicine, and other spaces. As all these programs move into late-stage clinical trials and commercialization is in reach, have you thought about the coming challenges to reach the market?

Inefficient quality systems, lack of proper analytics, and inability to scale up and out your process can derail your hard work and stop your momentum in its tracks. To avoid delays and added expense, it's crucial to partner with a contract development and manufacturing organization (CDMO) with a history of both success and stability.

With a legacy that spans over 75 years, Charles River is an established contract research organization (CRO) and CDMO that supports clients in all phases, from drug discovery and development through commercialization. Learn more about our Cell Therapy manufacturing capabilities.

Having gone through three successful audits for commercial cell therapies for both the US and Europe, you can depend on our regulatory expertise and global network of facilities to not only get you up and running for phase II and III trials quickly, but also keep you moving until your product is approved and on the market.

As a concept to cure partner, we have distinguished ourselves as the first North American CDMO to earn approval from the European Medicines Agency (EMA) to commercially produce an allogeneic cell therapy drug product. This innovation, combined with the highest quality standards, is how we've conducted more than 1,000 studies in cell and gene therapies, including supporting the development of 20 of those approved by the Food and Drug Administration (FDA).

Inspections with other health agencies continues as we look to expand our approval for commercial production into additional geographies.

Accelerate and Scale Your Cell Therapy Products

We've honed our capabilities to meet the increasing demand for faster, more scalable cell therapy solutions through strategic investments in state-of-the-art facilities, cutting-edge technologies with automated and closed systems, and a dedicated team of highly skilled professionals. As a result, you can accelerate your development timelines with streamlined processes and optimized manufacturing protocols. Learn more about our off-the-shelf Flex Platforms for Cell Therapy processes.

We do this by:

• Starting with the end in mind and avoiding common late-phase Chemistry, Manufacturing, and Controls (CMC) challenges of CGT manufacturing
• Identifying, assessing, and managing risk at each stage of cell therapy commercialization
• Leveraging an integrated CGT workflow that eliminates common pain points with our tech transfer, digital customer portal, Apollo™ platform, project management team, and scientific and regulatory advisors (SAS)
• Comprehensive portfolio of in-house contamination control and biosafety testing
• Maintaining a state of inspection readiness to facilitate smooth market entry
• Having a robust supply chain that includes temperature-controlled storage and shipment

As part of our commitment to excellence in clinical and commercial manufacturing, we have continued to expand our global network with over 110 facilities across more than 20 countries, and currently our CDMO center of excellence in Memphis manufactures two cell therapy drug products, including Vertex's CASGEVY™ therapy.

GMP compliant, the Memphis site offers three suite configurations that facilitate scaling and are ISO 7 Grade B for cell culture, cell therapy production, and viral transduction.

With the capacity and capability to provide a robust and reliable manufacturing process for your cell therapy products, we'll support your commercialization journey every step of the way.

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