DAVID O’CONNELL
PCI Pharma Services, Gwent, United Kingdom

Abstract

The pharmaceutical landscape continues to evolve, with much R&D focusing on more specialised medicines. As the biological activity and specificity of the API increases, dosage strengths decrease – resulting in increased potency of the APIs in terms of occupational handling for drug product manufacture. The marketplace is seeing continued investment in R&D with a visible shift towards speciality/potent medicines, and oncology a particularly intense area of focus for the global pharmaceutical sector. 

Leaders in the development and manufacturing of potent molecules with specialist containment technology provide expertise in the safe and successful management of highly potent active pharmaceutical ingredients (HPAPIs). Here, PCI shares (insights from) its experience.

WHAT IS A POTENT MOLECULE?

Although there is no standard classification for the potency of pharmaceuticals, all potent molecules can be defined as powerfully active, noxious materials needing only very small quantities to have an effect. All substances are potential poisons, since no chemical is completely safe; it is the dosage that distinguishes a poison from a remedy, with ‘safe’ chemicals being ‘toxic’ at high enough concentrations and even very ‘toxic’ chemicals deemed ‘safe’ if exposure is low enough.

APIs are deemed potent if they fall into one of the following categories:

• A pharmacologically active ingredient or intermediate with biological activity at approximately 15 micrograms (µg) per kilogram of body weight or below in humans, or a therapeutic daily dose of 1 milligrams (mg) or below per day
• An active pharmaceutical ingredient or intermediate with high selectivity (as in the ability to bind to specific receptors or inhibit specific enzymes) and/or the potential to cause cancer, mutations, developmental effects or reproductive toxicity at low doses
• A novel compound of unknow ...
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