Alteration in Dissolution Characteristics of Gelatin-Containing Formulations: A Review of the Problem, Test Methods, and Solutions

This 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.

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

The company now performs product-sterility testing through rapid microbiological methods at two laboratory sites in the United States and one in Germany.