news
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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QA/QC
news
European Pharmacopoeia publishes new data quality framework
New general chapter on quality of data 5.38 supports stakeholders with digitalisation during pharmaceutical quality decision-making.
news
Endotoxins research supports recombinant reagent use for pharma QC
Replacing LAL reagents with animal-free alternatives addresses industry commitments to improve QC practices’ ethics and sustainability.
news
Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
webinar
Harnessing digital PCR for rapid sterility testing
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.
webinar
Practical considerations for aseptic gowning in contamination control strategies
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.
news
European Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
webinar
Realising autonomous pharmaceutical operations
2 December 2025 | By Emerson
Is operational complexity limiting your performance? Discover how autonomous technologies are reducing risk and improving quality in pharma organisations.
article
European Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
news
Novel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
news
Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
news
Raman-based PAT tool could advance continuous vaccine manufacturing
Study demonstrates the non-invasive tool’s potential for real-time monitoring of cytomegalovirus (CMV) viral particles.
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Novo Nordisk manufacturing facility, and clients, hit by FDA action
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
webinar
Automating quality control testing for radiopharmaceutical production
7 October 2025 | By Rapid Micro Biosystems
This webinar showcased a rapid microbial method that can help to address the time to result challenge posed by short shelf-life radiopharmaceuticals.
news
Novel analytical approach could aid quality control during nitrosamine analysis
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
