August 29th 2025
Unichem Pharmaceuticals has issued a voluntary recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after the incorrect label was placed on the wrong product.
How Smart Technology Is Helping Reach Sustainability Goals in Drug Packaging
June 7th 2025Smart technologies, such as digital and laser printing, incorporated into manufacturing equipment are helping manufacturers align with sustainability goals, according to Sheikh Akbar Ali, general manager and head of Development and Technology for ACG Packaging Materials.
Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck
May 28th 2025Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.
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.