White Paper

High Potency Drug Manufacturing: Molecule To Market

Pharmaceutical Manufacturing

PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients (HPAPI) project. Backed by 30 years’ experience of managing potent molecules, PCI Pharma Services is the logical choice when selecting an outsourcing high potency drug manufacturing partner.

The pharmaceutical landscape continues to evolve, with much R&D focusing on more specialized 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. At PCI, we are seeing continued investment in R&D with a visible shift towards speciality/potent medicines, with oncology being a particularly intense area of focus for the global pharmaceutical market. Latest data suggests approximately 25 per cent of New Chemical Entities (NCEs) in development are deemed potent.

With this evolving landscape, pharmaceutical product developers and manufacturers have had to rethink their approach, as greater potency medicines generate increasingly complex regulatory requirements. With such a significant proportion of new drugs in development containing high potency APIs, the processing of such molecules presents many challenges, not least of which is the need for significant investment in specialised containment resources to ensure that employees and their environment are protected from exposure to these drug compounds.

This paper examines the process of successful high potency drug manufacturing and delivery to market.

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