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Research calls for regulators to accelerate the approval of antibiotics
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
List view / Grid view
Microbiology
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Ensuring adequate sanitisation: disinfectant-resistant microbes in cleanrooms
Here, EPR summarises a paper that asks whether cleanroom sanitisation procedures are adequate, discussing the emerging problem of microbial resistance to disinfectants.
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Microbial risks presented by aging facilities
Here, EPR summarises the microbial contamination concerns that may arise from aging facilities presented in an article by Tim Sandle.
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Optimising Bacillus spores for sporicidal efficacy assessments
Study reveals that different Bacillus strains sporulate better in different media and conditions, establishing optimal parameters to produce spores for disinfectant efficacy studies.
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Controlling contamination by material transfer
Here, EPR summarises Tim Sandle's review of different methods for transferring items into aseptic areas, including decontamination chambers and pass-through hatches.
whitepaper
ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
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Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
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Testing non-inferiority for accuracy of quantitative microbiological methods
Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
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The importance of sterility testing in biopharmaceutical manufacturing
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
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QA/QC Microbiology/RMM In-Depth Focus 2022
Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.
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Machine learning model enables adventitious agent detection in cell cultures
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
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European Pharmaceutical Review Issue 3 2022
In this issue experts explore the development of targeted protein degradation drugs, how potential legislative changes may impact the EU and selecting the right downstream process for bi-specific antibodies. Also featured in this journal, how RMM can enable efficient shutdown recovery, five critical areas for data integrity in life sciences…
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Standard for antibiotic manufacturing to help combat AMR
The standard requires antibiotics manufacturers to have effective environmental management systems in order to minimise pharma’s role in spread of environmental antimicrobial resistance (AMR).
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Detecting and eradicating mycoplasmas in ATMP cell lines
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
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Resources: Single use technologies – the ultimate future
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
