Q: How do you know which contract development and manufacturing organization (CDMO) is right for you?
With Keith Kentala, Vice President, Commercial Operations
A: There is quite a lot to think about when selecting a CDMO to partner with, and I like to think of it as a ledger with two sides. On the left, you have easily articulated needs and tangible requirements, what I think of as the “pots and pans and people” — meaning, does the organization have the technology, equipment, capacity, and know-how to develop and manufacture the type of product you have. On the right side are the less tangible, but equally important qualities of relationship and culture that are necessary to give you confidence in their ability, not only to get the job done, but to work well with you along the way, exceeding timelines and expectations. The best sponsor/CDMO relationships are true partnerships.
To break it down further, I would look for scientific strength and state-of-the-art assets. If they don’t have both, don’t bother.
To judge a CDMO’s scientific strength, I would ask for an analysis of the programs and products they’ve brought to market; does their portfolio have complex products? Ones similar to yours? Have they brought a product like yours to market before?
Even if the CDMO doesn’t own the final product, it’s important to know their scientists are experienced in taking a product to commercial approval. It’s a huge disappointment to have a regulatory failure because of CMC (Chemistry, Manufacturing, and Controls) concerns, so make sure your CDMO has the scientific expertise and quality systems to do everything in its power to ensure success.
As for its assets, you’ll want to know what equipment train and technologies they would use for your project, and what are the ages and reliability of those assets? Are they capable of cutting-edge process controls? In addition, meet the manufacturing team members assigned to your project; what is their experience with product like yours, on the selected equipment?
Understanding the scientific strength and state-of-the-art assets serves as a strong foundation for your decision. Build on that by assessing the CDMO’s culture and quality of relationship you can build with them. If you can assess both the left and right sides of the ledger, you’ll be more satisfied with your working relationship and more likely to achieve product success.