Challenges encountered when implementing a continuous monitoring system are reviewed.
There are a number of challenges when implementing a continuous monitoring system.
The author presents issues encountered at Novo Nordisk and discusses how expanding the scope of monitoring, together with frequent and thorough review of data, can help keep a facility in compliance.
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Pharmaceutical Technology’s 2014 Bioprocessing and Sterile Manufacturing eBook.
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.