whitepaper
Future of QA/QC for Complex Biologics Whitepaper
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
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Rapid Microbiological Methods (RMMs)
news
Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
news
Infrared thermography can detect pre-visual bacterial growth, shows study
A new paper shows thermal imaging (infrared thermography) can detect E. coli and S. aureus bacteria after just six hours of incubation, long before it is visible to the human eye.
news
Understanding limitations of microbial detection methods is key, says expert
Microbial detection methods are inherently flawed by three key factors, here we summarise Tim Sandle’s explanation of the concerns surrounding microbial methods and sampling.
news
FDA suggests principles for implementing bio-fluorescent particle counters
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
video
Discussing developments in RMM with Dr Tim Sandle, Bio Products Laboratory
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
article
Primary validation of the growth direct bioburden system and media
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
webinar
The analytical reality of recombinant endotoxin technologies
29 July 2020 | By Charles River
In this webinar we discuss the results of our latest study where we evaluated the ruggedness, repeatability and specificity of commercially available rFC products, as well as our own recombinant product in development, against a large panel of endotoxins.
article
Rapid microbiological methods: A looking glass into what and how we are
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
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
QA/QC & Analytical Techniques In-Depth Focus 2020
Within this in-depth focus are features on the uses of Raman imaging in the pharmaceutical industry and the benefits of utilising rapid microbiological methods (RMM).
article
European Pharmaceutical Review Issue 3 2020
In this issue is a discussion on the promise of virally vectored DNA and mRNA vaccines to combat COVID-19 as well as articles on how packaging could help to ensure patient adherence, regulatory issues for medicines and diagnostics during the pandemic and the benefits of digitalising the pharmaceutical supply chain.…
whitepaper
Whitepaper: Does QRM + RMM = Better EM
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
article
Do viability methods detect all viable organisms?
Many bacterial species have been found to exist in a viable but non-culturable state. Jeanne Moldenhauer discusses this phenomenon and makes suggestions as to why we don’t often see an increase in viable cells when using viability-based methods.
video
On-demand webinar: Streamline your Rapid Microbiological Method Validation
When it comes to microbial contamination testing, false results can waste valuable time.
