Getting a Handle on High Potency
We need to optimize and then accelerate HPAPI drug product development
Alyn McNaughton | | Opinion
New treatments under development are increasingly specialized, selective, and potent. Highly potent API (HPAPI) compounds are designed to be more effective at the site of therapy while minimizing adverse events. The manufacture of HPAPIs, however, comes with significant challenges. By their very nature, HPAPIs are often toxic to the workers who manufacture them, necessitating a high degree of controlled handling. Additionally, the low concentrations typically required for administration make accurate dosing more challenging – each dose may only contain the equivalent of a single particle of the API as supplied from the manufacturing process. Furthermore, these new molecules are often poorly soluble to insoluble, causing bioavailability issues.
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