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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.
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.
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
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.
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…
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.
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
Increasing uses of high-performance liquid chromatography (HPLC) and rising healthcare investment driving market growth, finds report.
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
![Lonza Logo on top of grey building in Basel, Switzerland [Credit: Taljat David / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-1-300x278.jpg)
![Lonza Logo on top of grey building in Basel, Switzerland [Credit: Taljat David / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-1-e1654774052980.jpg)
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.
Find out how a pharma company maintained product quality and reduced plate counts by 25 percent using a rapid microbial monitoring analyser – the 7000RMS.
Here, EPR summarises a recent review, outlining the critical considerations when setting occupational exposure limits (OELs), with a focus on HPAPIs.
