How to go from API to PAI

The power of using an integrated approach when transitioning a small molecule from drug discovery to drug development

The aim of every drug discovery program is to launch a drug onto the market that addresses the previously unmet needs of patients with serious, and sometimes life threatening, diseases.

The road to market though is long, risky and expensive.

When it is the time to obtain approval for the commercial manufacture of a small molecule Active Pharmaceutical Ingredient (API) for use in the US market, the FDA is likely to audit the production facility in a Pre-Approval Inspection (PAI).

The purpose of the inspection is to establish that the proposed manufacturing process and analytical methods are under control and capable of consistently producing your API to defined quality standards.

Which are the key questions that may be asked during the inspection?

Learn about them (and much more) in this article, written by our expert Petra Dieterich, where she discusses about the benefits of applying an integrated approach at the crossover between discovery and development. 

You will also learn how the appropriate application of skill sets from process development, analytical chemistry and solid state sciences can benefit your API development program by ensuring that critical decisions are taken with the benefit of the foresight gained by many years of API development experience, culminating in a successful application to market your drug.

About the author


Dieterich Petra bw

Dr Petra Dieterich, Technical Business Development, Evotec

Petra Dieterich has 25 years’ experience of working in drug development with a focus on CMC activities. A PhD chemist by training, Petra spent 3 years at Cyanamid before joining Oxford Asymmetry where she gained extensive experience working in a CRO environment, leading projects for Biotech companies in the development of API’s for clinical trials and commercial use. Petra has held several management positions, becoming head of site for Aptuit Oxford. In 2018 she was awarded an MBA from Imperial College London and is now Vice President of Technical Business Development, shaping integrated CMC project opportunities for clients in Europe, USA and Asia.

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