Recommended

Register now: Enhancing biopharma workflows with the power of UV/Vis spectroscopy webinar
Download our brand new eBook: A practical guide to single-use filtration in biopharma.
Join us as we look at how the outsourcing of buffers is helping biopharma drug manufacturers to streamline their processes.
Discover more on how Polpharma API meets evolving regulatory guidance around N-nitrosamines control in APIs with Waters’ high-performance analysis instruments.
Learn more about leveraging real-world data, the practical applications of AI and adopting configurable LC/NC solutions.
Download this compendium to discover how hot-melt extrusion can help to overcome pharmaceutical formulation challenges
article

The challenge of handling highly potent API and ADCs in analytical chemistry

Handling highly potent active pharmaceutical ingredients (HPAPIs) or drug product in a laboratory requires implementation of strict security measures. Here, Elodie Barrau and Olivia Jones discuss high potency product handling procedures to ensure continued safety.

HIGHLY POTENT active pharmaceutical ingredients (HPAPIs) products are classified based on their toxicity through occupational exposure limits (OELs). These molecules are proven to be effective at much smaller dosage levels than traditional APIs. Some examples of HPAPIs are cytotoxic compounds and hormones such as oestrogen.

What defines ‘high potency’?

A high potency (HP) active ingredient or intermediate is generally defined as:

  • Having an OEL of 10 μg/m3
  • Having a biological activity in humans from a concentration of approximately 150 μg/kg of body weight
  • Having high selectivity (ie, ability to bind to specific receptors or inhibit specific enzymes)
  • Having the potential to cause cancers, mutations, developmental effects or reproductive toxicity at low doses
  • A new compound of unknown potency and toxicity.

Over 25 percent of total drugs worldwide are classified as containing HP compounds and 30 percent of product candidates in the development pipeline are also HPAPIs, showing that this trend will continue.1,2

During the last decade demand for analytical chemistry on HPAPIs has grown rapidly, mainly due to advances in clinical pharmacology and oncology research. All dosage forms may utilise HPAPIs including parenteral and solid dosage forms. There is particular interest in antibody drug conjugates (ADCs), which use monoclonal antibodies (mAbs) to selectively deliver HPAPIs to specific cancer tumours.