JUSTIN MASON-HOME
HPAPI Project Services Limited, United Kingdom

Abstract

Potent and highly potent active pharmaceutical ingredients (HPAPIs) constitute a large proportion of pharma pipelines and a market with a reported worth of over $32 Billion by the end of 2026.  With higher potency and potential therapeutic benefits that smaller doses of more targeted drugs may bring to the patient, comes increased risk to businesses and in particular, their workers.  Management of potent drug safety is, or at least should be, a systematic and scientific endeavour.  Application of robust science in a hard-nosed pharma business context, can help companies understand potent drug hazard, risk and control and direct building operational assets and not liabilities.

It seems that everyone is talking about highly potent active pharmaceutical ingredients or ‘HPAPIs’.  What happened to good old regular potent APIs (PAPIs?)?  And what’s in a name anyway?

It is certainly the case that (bio)pharma companies have been delivering higher potency and toxicity APIs consistently over the last 20 years.  

Smaller patient therapeutic doses sometimes have the potential to deliver reduced side-effects and effective targeting of drugs to their site of action, most stark in the exciting world of antibody drug conjugates (ADCs), enable truly highly potent and toxic APIs to be elegantly transported to right where they can exert their maximum therapeutic effect.  We have only just begun this journey.

Higher potency drugs may bode well for the patient, but less so for healthy (bio)pharma workers, who may as part of their daily employment, come into contact with thousands or even millions of therapeutic doses!