Summary: Dr. Richard Castledine, Head of Operations - Alnwick, UK at Arcinova, A Quotient Sciences Company, outlines how drug developers can overcome API synthesis challenges by focusing on early route design, solid-state analysis, and scalable, cost-effective processes. He emphasizes the importance of selecting safe, sustainable synthetic pathways and using data-driven strategies to mitigate downstream risks.
Developing an active pharmaceutical ingredient (API) involves balancing quality and speed during the transition from candidate selection to first-in-human (FIH) clinical trials.
Creating a safe, cost-efficient, and regulatory-compliant API production method is crucial to avoid costly repeat activities or bridging studies later in the development process. Analytical techniques, including solid state analysis, are essential for understanding how changes in the synthetic process influence API properties, especially for small-molecule oral solid-dose drugs.
In this article, Dr. Richard Castledine shares some of the considerations that drug developers and their partners face in drug substance API synthesis.
What is an “API” in drug manufacturing?
An Active Pharmaceutical Ingredient (API) is the substance which offers a therapeutic effect in a pharmaceutical product, and is responsible for the drug’s pharmacological activity within the body. It is combined with excipients which aid in the delivery of the API but do not themselves have any pharmacological activity.
What is process route design in API manufacturing?
Process route design involves finding and selecting a synthetic pathway to the API which has favorable characteristics for large scale current Good Manufacturing Practice (cGMP) production. Modification or redesign of the process is often required to prepare larger batch sizes and ensure that API can be produced in a compliant and efficient manner.
What factors must be considered in optimizing API?
A targeted approach is best for obtaining insight into an APIs physical and chemical properties, as well as the potential limitations that may occur in the manufacturing phase. Deploying data-driven API development strategies early in a program can mitigate downstream development risks.
Choosing a CRDMO development partner with extensive expertise in developing and analyzing API is crucial, along with using a holistic approach to process development that avoids delays and costs while facilitating efficient API scale-up.
To read more on this topic, visit Arcinova's blog.