Nat Hastings and Peter Bach of Cellestial Health found themselves at a beautiful Alfasigma CDMO facility in Pomezia last week as part of the Proventa International Innovation Day.
When should manufacturing, formulation, and clinical supply be considered in the course of therapeutics development?
It became clear that no matter what stage the product is, the answer is “Now”.
✦ Target product profile is the guiding star of the development program
✦ Desired route and frequency of administration based on patient needs dictate preferred formulation and physicochemical properties
✦ Medicinal chemistry should aim to screen for the most suitable molecules with relevant characteristics – even if “perfect” is not possible
Some aspects of biology and chemistry in early development carry inherent risks that we have to accept and mitigate, but there is no reason to be unprepared to scale from the manufacturing and formulation perspectives.
Thank-you once again to Proventa International and Alfasigma Italia for hosting our delegation.
