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process can also ensure that as scale increases and the route becomes fixed along with the impurity profile, no new forms emerge to derail the development programme and subsequently lead to costly delays. At this point, a process risk assessment should also be introduced supported by a robust form and crystallization development programme. From a worst-case-scenario perspective, the absence of such a thorough evaluation may mean that developers could see the emergence of new stable forms post-release and commercial manufacture.


Final thought


The identification of an ideal solid form of an API not only improves the PK profile of a drug but can result in more streamlined manufacturing workflows and increased product stability. The collaborative approach created by having multiple groups work together (medicinal chemists, solid form scientists, development chemists, and formulation scientists) cannot be underestimated, and the importance of solid-state considerations at all stages of development programmes is becoming more widely acknowledged. Changes in impurity profiles, processing conditions and excipients can influence the solid form of the API and require careful monitoring throughout the drug


Life Sciences Focus: Drug Development


There is a growing realization from pharmaceutical developers that active pharmaceutical ingredient (API) development and manufacturing requires a more interactive approach with collaborative input from multiple groups, including medicinal chemists, solid form scientists, development chemists, and formulation scientists


development lifecycle. The solid form of an API will have a significant impact on drug development activities; therefore, appropriately placed studies will help to develop an extensive understanding of the solid form


landscape and provide the aforementioned ‘road map’ for development, avoiding unwanted solid form transformations. Building a strategy for solid-state that is phase-appropriate and considers the necessary requirements at the right time can be a useful tool in establishing a more efficient and cost-effective path to market.


AT: +44-(0)191 5166507 E: Julian.northen@onyxipca.com


About the Author


Jules Northen, Research Manager, Onyx Scientific. As Research Manager, Jules Northern is Onyx’s resident expert in solid-state chemistry development, covering screening, crystallization and candidate selection. With more than 15 years’ experience in the field, hedrives Onyx’s solid-state group and integrates with lead optimization services including process and development (PR&D) projects for Phase 1 studies through to Phase 3/commercial API development and manufacturing.


Summer 2020


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