Dr Michael J. Miller joins Spore.Bio as VP of Scientific and Regulatory Affairs
The French start-up focuses on advancing rapid microbiology in manufacturing quality control.
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The French start-up focuses on advancing rapid microbiology in manufacturing quality control.
But the sector’s digital transformation ambitions within their quality functions have only been partially realised.
The critical role of identification and documentation in contamination control.
New general chapter on quality of data 5.38 supports stakeholders with digitalisation during pharmaceutical quality decision-making.
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
News organisation ProPublica’s Rx Inspector tool connects FDA information on factory location and regulatory records to individual generic drugs.
5 January 2026 | By Sartorius
Join this webinar to explore rapid sterility testing methods that ensure fast, reliable product release, addressing critical challenges in timely delivery and safety.
The impurities research illustrates an approach that could offer a simpler and more flexible downstream purification process.
17 December 2025 | By Particle Measuring Systems
Join this webinar as we examine the main personnel-related factors that could lead to particle/microbial contamination risks of the product and outline practical measures that can mitigate these risks.
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
Nippon Muki demonstrates the performance advantages of its innovative HEPA filter for the sterilisation of injectable containers in pharmaceutical manufacturing.
2 December 2025 | By Emerson
Is operational complexity limiting your performance? Discover how autonomous technologies are reducing risk and improving quality in pharma organisations.
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.