Highly potent molecules: safe, effective processingBy David O’Connell, Director of Scientific Affairs at PCI Pharma Services - 3rd September 2018
- A pharmacologically active ingredient or intermediate with biological activity at approximately 15 µg per kg of body weight or below in humans, or a therapeutic daily dose of 1 mg or less per day
- An API or intermediate with high selectivity and/or the potential to cause cancer, mutations, developmental effects or reproductive toxicity at low doses
- A novel compound of unknown potency and toxicity.
Assessment and management of HPAPIs
The number of contract development and manufacturing organizations (CDMOs) claiming to offer potent processing capabilities has increased in recent years, but they may not have invested in contained technology – meaning a heavy reliance on personal protective equipment (PPE).
Any CDMO working within drug product development should be aware of the level of toxicology data available and risk assessments to ensure workforce protection. Emphasis should be placed on an on-boarding process for suitable handling of the API.