PC imaging wages war on particle contamination

Recent drug recalls stemming from particle contamination highlight just how exacting processes are in pharma manufacturing. But thanks to increasing horsepower in both personal computers and digital cameras, pharma operators have a tool to help tame the particle beast.

PC-based image analysis can aid operators in defining process end-points and rationalizing differences between batches, says Deborah Huck of particle-analysis instrument maker Malvern, in ChemEurope.com. She describes how one manufacturer suffered repeated excipient batch failures that were discovered late in the manufacturing process because its microscopy or ensemble sizing methods were incapable of distinguishing good batches from bad.

Via automated image analysis, however, operators could evaluate the average convexity--a measure of particle surface roughness--of each excipient batch. Failed batches consistently had lower average convexity than good batches, and so could identify bad batches before they were used.

- here's the article


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.