The use of CDMOs (Contract Development and Manufacturing Organizations) in the pharmaceutical and biotech industries has increased significantly in recent years and patterns have emerged regarding CDMO usefulness vis-a-vis sponsor needs through the various stages of development. Industry Standards Research (“ISR”) explored these patterns, and the results are interesting. The data shows that there are shifts in CDMO type from early phase manufacturing, later phase manufacturing, and commercialization. These shifts happen based on the level of risk the manufacturer is willing to take and the level of investment it plans to make at each stage.
In the preclinical stage of manufacturing, large global CDMOs are less likely to be used as opposed to smaller, niche CDMOs. The smaller, niche CDMOs seem to be more accessible for sponsors at this early stage than are the larger, global players in the market. The smaller CDMOs tend to be more flexible and can provide time for troubleshooting and make changes at the drop of a dime, whereas larger CDMOs maintain a process for more routine manufacturing scenarios that are known and proven.
Sponsor companies in the later-phase stage of manufacturing tend to use larger, global CDMOs that have the scale and workforce necessary for a stable and predictable process and outcome. In addition, the sponsor tends to want to stick with a CDMO throughout late phase and commercialization. It is perceived easier and less risky – at a time when reducing risk matters.
As we have seen in recent Cell & Gene articles by Mark Roach, QxP’s VP of Cell and Gene Therapies, there is always a tension when choosing the right CDMO.
What You Should Expect From A High-Functioning CDMO: Part 1
What You Should Expect from A High-Functioning CDMO: Part 2
Building the relationship and trust is key, and so is knowing the strengths of the CDMO and ensuring those strengths are what the sponsor needs for the stage of development. The specifics may be different from one provider to another, but the key is building trust and doing research to mitigate risk and improve the likelihood of success.
The QxP team has seen these differences among CDMOs up-close and supports sponsors as they choose, and then manage, CDMOs. Please email me at cfeaster@qualityexecutivepartners.com if you would like more information.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
Check out Christine’s other recent blogs: “Nitrosamines Impurity Challenges” and “Bacterial Endotoxin Testing is on the Move.”
