How early should you engage a CDMO?
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Engaging a CDMO early helps clarify technical requirements and risks, but CMC decisions should not be locked in before clinical and nonclinical evidence is in place. A company working on a poorly soluble API produced an engineering batch with a solubility-enhancement approach before PK and toxicology studies were completed, then had to redo the work, delaying its IND filing and clinical trial start. Another program took a phase-appropriate strategy, using fit-for-purpose clinical supply to support the IND filing and advancing process and scale-up development based on the data.
Excerpted from BioPharma Dive
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- BioPharma DiveHow early should you engage a CDMO?
Engaging a CDMO early helps clarify technical requirements and risks, but CMC decisions should not be locked in before clinical and nonclinical evidence is in place. A company working on a poorly soluble API produced an engineering batch with a solubility-enhancement approach before PK and toxicology studies were completed, then had to redo the work, delaying its IND filing and clinical trial start. Another program took a phase-appropriate strategy, using fit-for-purpose clinical supply to support the IND filing and advancing process and scale-up development based on the data.
Coverage and heat for this story
Reports so far 1·Heat now 9·Peak heat 10 (Oct 19 17:00)·Reports, 24h +1
Two panels, same clock (pointer stays in sync): top is cumulative editorial reports — only rises; last point = All reports; slope = new reports that hour. Bottom is Live-board heatIndex — 7-day participants with a 24-hour half-life, so it can fall when talk cools.