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Articles & Publications , Dr. Paul Quigley , John McDermott

DCAT Value Chain Insights - CDMO Roundtable: Managing Orphan Drug Projects

Low-volume drugs, such as orphan drugs, present challenges in achieving favorable production economics and in managing the projects themselves. A roundtable of CDMOs provides perspectives on those challenges and best practices to resolve them. 

Quotient Sciences experts contributed insight to this recent article with DCAT Value Chain Insights. Read what Dr. Paul Quigley, Principal Research Fellow, Drug Substance, and John McDermott, Executive Drug Development Consultant, had to share about developments in rare diseases.

Read the full interview


Q: What particular challenges arise from a supply planning/management perspective when working with low-volume drugs?

Paul: Most CDMOs are dependent on large-volume processes to achieve economies of scale. We take a material-sparing mindset when developing scalable manufacturing processes, which is particularly important for low-volume drugs.


Q: Any particular challenges when scaling up from clinical to commercial scale when working with a low-volume drug? 

John: If the process of scale-up is well understood and there are appropriate processes in place to manage the scale-up from clinical to commercial scale, this shouldn’t present a technical problem as by definition low-volume drugs sit somewhere along the scale spectrum. However, low-volume drugs require expertise in controlling processes at the intended scale, sometimes with equipment that can be difficult to find in late-stage and commercial production.