DCAT Value Chain Insights - CDMO Roundtable: Managing Orphan Drug Projects
Supply management and low-volume drugs:
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.
Clinical to commercial scale-up
Q: How about scale-up? Any particular challenges when scaling up from clinical to commercial scale when working with a low-volume drug? If so, how is that resolved?
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.