Selecting a CDMO

How to select a CDMO that best fits your needs.

A CDMO is a Contract Development and Manufacturing Organization. These organizations provide a critical service to companies developing cell and gene therapies for clinical trial and commercial supply. A CDMO provides development services that improve the quality and scalability of the cell or gene therapy and then produces the mass manufacturing required once a therapy is approved for clinical trial and eventual distribution in the market.

  1. 01The Growth of the CDMO market
  2. 02Communication and Transparency
  3. 03Flexibility
  4. 04Capability

Communication and Transparency

Does the CDMO understand and align with your company’s milestones?

  • Is there a culture fit between the CDMO and your company?
  • Does the CDMO demonstrate that your company’s business is important to them?
  • Does the CDMO have a dedicated project manager to coordinate with your company?
  • How does the CDMO handle patient product delays, clinical delays, or budgetary changes?
  • How does the CDMO handle scheduling changes for Qc release testing to ensure the safety and quality of the product?


Can the CDMO adapt to your company’s changing needs over time?

Process Development and Phase I

  • Does the CDMO offer tailored budgeting that reflects your company’s involvement in process development and manufacturing?
  • Can the CDMO handle delays or difficulty in patient recruitment or schedule changes?
  • Does the CDMO offer phase-appropriate development and Qc testing?

Phase II and Beyond

  • Does the CDMO provide Validated Qc testing? Is this done in-house?
  • Can the CDMO handle increased production volume when needed?
  • Does the CDMO provide shift work to ensure eligible patients receive therapy?
  • Is there coordination between the production and the Qc teams?
  • Is the CDMO experienced in shipping and compliance with various regulatory authorities, i.e. FDA, EMA, and Health Canada?


Can the CDMO deliver?

What is the reputation of the CDMO?

  • Can the CDMO provide references from previous clients?
  • Do key CDMO staff have the required experience, or is there over-promotion?
  • Does the CDMO team ask and answer questions demonstrating the required scientific and technical expertise?
  • Is there a high turnover? Does the CDMO have a recruitment + training plan?
  • Does the CDMO need to bring in many partners to get the job done?

Can the CDMO deliver a high-quality product on time and on budget?

  • What is the CDMO’s production success rate, including deviations?
  • How many clinical products have they produced?
  • Is Qc testing done in-house or outsourced?
  • Is there a timely Qc release and quality of testing results?
  • Any product recalls or worse?