The pharmaceutical industry is increasingly focused on drug products containing highly potent active pharmaceutical ingredients (HPAPIs). These compounds are highly effective at very low doses, but due to their toxicity they also pose significant risks to operators. The introduction and scaling up of HPAPIs in manufacturing facilities involve complex challenges requiring specialised expertise and stringent safety protocols.

Drug products containing HPAPIs account for around 40% of authorised drug products on the market today. In 2023, the OSD market was approximately $36.5bn, and is poised to register a compound annual growth rate (CAGR) of around 6% by the year 2030. Within this space, the main drivers for growth include oncology, diabetes and obesity drugs, the latter experiencing a boom due to the role of GLP-1 therapies in weight loss management.

As the demand grows, a robust approach to new product introduction (NPI) and technical transfer (TT) becomes increasingly essential. The processes for handling and on-boarding HPAPIs can be difficult due to the inherent risks associated with these substances, with the key challenges including categorisation, risk classification, containment, process flow, and ensuring robust cleaning methods to prevent cross-contamination in a multiproduct facility.

Handling HPAPIs

HPAPIs are designed to elicit a biological response at very low doses, making them highly potent but also highly toxic. Whereas during administration the product’s highly targeted yet toxic profile ensures that fewer side effects are experienced by the patient, they pose a significant risk to CDMO production operators if they’re not handled correctly. Ensuring the safety of production workers and patients therefore requires meticulous control and monitoring, which begins during TT and NPI, but the lack of standardised monitoring tools and methods to ensure the safety of production environments remains a challenge.