Engage with your CMO early
There, he and his colleagues help drug developers solve problems regarding formulation and manufacturing of drug candidates as well as commercial pharmaceuticals.
The Cork team follows a materials science approach using the Materials Science Tetrahedron that enables to gather information about the structure, processing, properties and performance characteristics of the Active Pharmaceutical Ingredient (API) which in the next steps is used to create a formulation of a candidate drug product or to establish a manufacturing process.
– Our core expertise is delivering data on key material physical properties attributes, but we are particularly strong at applying this data to solve material science challenges. When customers come to us with a problem, I always insist on talking to the right people at the customer company – for example the experts associated with API supply – to make sure that we know exactly what the customer expectations are, Gordon Hutton says.
The team works with all phases of drug development – from preclinical studies, through clinical development, and to commercial production.
One example of a problem that they recently solved was a controlled release drug that had reached commercialization but there were challenges with optimizing the manufacturing process.
– The drug was released too fast, which could have been toxic to patients. We completed a significant body of work to understand what the problem was.
After ruling out many possible causes, they discovered that it was the API that caused the problem.
– It was forming tiny primary particles which formed cohesive agglomerates, which changed the release rate. We then went to the manufacturing site and made some changes in the crystallization process and now the drug product is performing correctly.
Gordon Hutton’s advice is to contact a CDMO as early as possible.
– Engage with your CMO early! The reality is that the attrition rate in product development is high and if a project does fail, the investment put into the development is lost. The demands on the formulation change a lot from preclinical development to the clinical phases and subsequent commercialization and large-scale production. Therefore, companies want to do the minimum amount of work on formulation for each stage and they also want to scale up production gradually. If they engage with a CMO as early as possible, they can receive help with planning how to do this, mitigate risk and form a good foundation early in development for subsequent scale up if the product is successful in the clinic.