Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.
Gelatin is commonly used for drug encapsulation. Ensuring that materials have optimal critical quality attributes for the required formulations is crucial, as are practices that will ensure an uninterrupted supply of quality material.
Jean-Philippe Talmon, chief procurement officer at Capsugel, shares best practices, for both natural and synthetic materials.
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Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.