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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.
Behind the Headlines Episode 16: NIH Funding, Re-Shoring, Tariffs, and Cell and Gene Therapies
April 29th 2025Donald Ingber, MD, PhD; Miguel Forte, MD, PhD; Ali Pashazadeh, MRCS, MBA; and Adam Inche, PhD, MBA go behind the headlines to examine the fast-changing landscape of manufacturing re-shoring, tariffs, NIH budget cuts, and the outlook for cell and gene therapies.