Low levels of some microorganisms that are present in oral solid dosage forms are unlikely to present a risk to patients. The amount of water activity in these products can help determine when microbiological testing should be conducted.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
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.