List view / Grid view
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
How important is collaboration in ATMP development? What can be done to expedite ATMP manufacturing and release? Find out about all this and more in this podcast with bioMérieux.
Join Rey Mali and Félix Montero-Julian as they discuss the challenges facing the manufacture and QC of advanced therapy medicinal products (ATMPs) and potential solutions.
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
Industry experts share their latest research and developments in pharma.
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
Read articles on validating rapid microbial methods according to regulatory requirements and how solid-state NMR spectroscopy can be used to analyse pharmaceuticals in this in-depth focus.
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.
The latest applications and advice from industry experts.
Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
