“Drug development is fraught with challenges, and for biotech companies the stakes are especially high. A promising candidate can fail for reasons that have little to do with biology and everything to do with poor physical attributes of the solid form of an API: poor solubility, stability issues, variable pharmacokinetics, or the wrong choice of salt and/or polymorph.
“The solid form of an API is generally fixed by Phase IIb, and making changes late in the process often means costly bridging studies and delays. The earlier developers consider the solid form properties for a molecule, and subsequent potential to modify these via crystal and particle engineering strategies, the better positioned they are to avoid setbacks in later development. Solid form science is not just a regulatory requirement; it’s an opportunity to strengthen intellectual property (IP), improve manufacturability, and accelerate progress from lab bench to clinic.”
Read our article in the One Nucleus Autumn/Winter edition to find out how we can help unlock the full potential of your molecule.
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