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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Analytical techniques
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On-demand webinar: Speed your biologic into phase 1-3 clinical trials
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
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Webinar: Comparator sourcing success
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
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Rapid method development to overcome challenges of bi-specific antibody purification
The landscape of biopharmaceutical manufacturing is changing, with complex molecules such as bi-specific antibodies (bsAbs) becoming increasingly prevalent. bsAbs are a large, structurally diverse family of molecules designed to recognise two targets and globally there are over 230 in development as promising therapies for cancer and other diseases. While they…
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Webinar: Responsibilities of specialised clinical supply experts
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
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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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AEX-MS to become increasingly important in antibody characterisation
Study shows AEX-MS enables the analysis of IgG4 Fc deamidation variants and, as IgG4 antibodies become more popular, could become increasingly valuable for antibody charge heterogeneity characterisation.
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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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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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Advancing nitrosamines analysis with gas chromatography
Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.
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Raman spectroscopy – a promising alternative approach for sterility testing
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
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Digital growth focus of Sanofi’s new Digital Accelerator
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
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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.
