whitepaper
Application note: Single temperature analysis for environmental monitoring samples
This application note explores how to determine the feasibility and the impact of the single temperature for environmental monitoring microorganisms.
List view / Grid view
bioMérieux
whitepaper
Application note: Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products
Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.
whitepaper
Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
whitepaper
Application note: Low Endotoxin Recovery case study
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
whitepaper
Whitepaper: rFC adoption for bacterial endotoxin testing
What is driving the adoption of rFC for BET? Alternative methods are the obvious sustainable solution for efficient manufacturing.
whitepaper
Application note: Tipping point – what is driving the adoption of rFC for bacterial endotoxin testing?
As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.
whitepaper
Product hub: Environmental monitoring: a critical and challenging requirement
Read about bioMérieux's new system, 3P® ENTERPRISE - an end-to-end solution that fully digitalises and automates the EM process.
whitepaper
Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
whitepaper
Product hub: 3P® connect EM-BODY connectivity
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
whitepaper
Application note: A new, more flexible endotoxin test platform
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
article
Article: Survey of the status of rFC and LAL equivalence determination
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.
whitepaper
Whitepaper: Recombinant factor C: new Ph. Eur. Chapter 2.6.32
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
article
Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
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.
whitepaper
Whitepaper: BioFire® mycoplasma solution: results in one hour, fully automated detection system
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.
article
Expert view: Improving the endotoxin test paradigm established by LAL
THE ADVANTAGES of the recombinant Factor C (rFC) test lie in its (a) scientific characterisation, (b) sustainability and (c) specificity. In light of diminishing horseshoe crab populations, sustainability has been mandated via regulations that include the concept of the “3 Rs”: replacement, reduction and refinement of analytical tests and reagents…
