Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
In this podcast, Allison Scott, Lynn Johnson and Miriam Guest discuss how cross-industry collaboration through working groups can support adoption of modern microbial methods.
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
15 March 2023 | By Nelson Labs
Watch this webinar to learn from Peter Cornelis, how to prevent endotoxins contamination during pharmaceutical production, as well as gain insights into sampling plans, test methods, and method optimisation.
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
Researchers have shown a combination of peracetic acid and ultraviolet light could improve microbial water quality in pharmaceutical water systems.
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
CER-001 is a potentially game-changing treatment for septic patients at high risk of acute kidney injury, suggested a ABIONYX Pharma VP.
Imaweld® is distinct due to its composition, which seals and welds tubes and highly endorsed in biopharma for cell membrane and cell culture applications
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.