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 eventually distributed in the market.
The Growth of the CDMO Market
The growth of the CDMO market has been substantial, accompanied by frequent investment and acquisition announcements.
The message from the market is that capacity is available, but capability is lacking. It’s not the square footage of clean rooms that leads to development and manufacturing difficulties but a lack of expertise. It can also be challenging for SMEs to get the same attention as big companies when dealing with CDMOs.
It’s essential to find a CDMO who truly values your business. How a CDMO treats your company during the evaluation stage speaks volumes about how the partnership could unfold.
Here are some key questions to ask during that critical process.
Expertise
Does the CDMO have the in-house expertise to translate your groundbreaking research into therapies?
- How many years of expertise does the CDMO have in CGT research and development?
- What is the CDMO’s production success rate, including deviations?
- How many clinical products have they produced?
- Does the CDMO already have a Drug Establishment License (DEL)?
- Is QC testing done in-house or outsourced?
- Is there a timely QC release and quality of testing results?
- Are there any product recalls or worse?
Flexibility
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?
Capability
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?
We are an extension of your team
C3i works as part of your team proudly blurring the lines between “you“ and “us” to the most desirable “we.” We are the CDMO for cell and gene therapy that fills the gap between your research and innovative patient therapies.