John Lee, Global Head of CGT Published in Cytotherapy – CGT Development: Selecting the Right CDMO

Cell and Gene Therapy Development: Selecting the Right Contract Development and Manufacturing Organization

In recent years, the number of cell and gene therapy (CGT) clinical trials has boomed, and so has the need for contract development and manufacturing organizations (CDMOs).  For any size biotech company developing CGT products,  selecting the right CDMO is crucial for successfully transitioning from early-phase development to commercialization. But how do you choose the right one?

John Lee, global head of cell & gene therapy at SK pharmteco, co-authored a recent paper in Cytotherapy, the official journal of the International Society of Cell and Gene Therapy (ISCT),  titled, “Contract development and manufacturing organization selection: critical considerations that can make or break your cell and gene therapy development.” This paper, a product of a roundtable discussion John and others participated in at the 2023 annual meeting of ISCT in Paris, explores seven key factors for choosing the right CDMO (contract development and manufacturing organization) to propel your CGT project forward.

1. Technical Expertise:  Look for a CDMO with experience in similar technologies to your project. Their past successes and existing intellectual property (IP) are indicators of their capabilities.
2. Regulatory Capabilities and Compliance:  A strong CDMO will have a proven track record of navigating regulatory requirements and adhering to quality management systems.
3. Analytical Capabilities and Tools:  Ensure the CDMO has the necessary equipment and expertise to perform the specific analyses your product requires. Look for a CDMO that embraces Quality by Design (QbD) and Failure Mode and Effects Analysis (FMEA) principles.
4. CDMO Timing: When selecting a CDMO, carefully consider your project timeline and budget. Clearly defined expectations will help establish a realistic timeline and avoid potential delays or cost overruns.
5. Scale-Up or Scale-Out for Commercial Supply:  Does your project require large-scale manufacturing?  Choose a CDMO with proven experience in scaling similar products. Their facilities, staffing, and equipment should be equipped to handle your specific needs.
6. Location and Regional Needs: While geographic proximity isn’t essential, it can simplify communication and collaboration. The CDMO should also have expertise in complying with your product’s regional regulatory requirements.
7. Quotations, Cost, and Risk-Sharing: A detailed Request for Proposal (RFP) will ensure CDMOs understand your project requirements and submit accurate bids. The CDMO’s financial stability is also a crucial factor to consider. Explore risk-sharing options to optimize outcomes for both parties.

Choosing the right CDMO is a critical decision that can significantly impact the success of your CGT development. By carefully evaluating these seven key considerations, you can select a partner with the expertise, resources, and commitment to help your project reach its full potential.

SK pharmteco has unified two world-class CDMOs, Philadelphia’s Center for Breakthrough Medicines and France’s Yposkesi, to offer a full range of services throughout the advanced therapies process, from R&D to manufacturing and commercialization, all with a global presence. Visit our CGT page to learn more about how we can turn your CGT into reality.