Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
The pharmaceutical laboratory meeting adds sessions on AI in labs, and quality in biologics, mRNA and analytics.
By utilising patient-derived instead of donor-derived platelets, the method could offer a safer approach to platelet transfusions.
Study demonstrates the non-invasive tool’s potential for real-time monitoring of cytomegalovirus (CMV) viral particles.
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
7 October 2025 | By Rapid Micro Biosystems
This webinar showcased a rapid microbial method that can help to address the time to result challenge posed by short shelf-life radiopharmaceuticals.
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
The right packaging is critical when it comes to preserving the quality, efficacy and safety of pharmaceutical and nutraceutical products. Here, Uwe Raupbach, R&D Engineer Desiccants, Sanner GmbH, answers some key questions about the need for environmental management in packaging, focusing on moisture and odour control, and the solutions available…
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
2 September 2025 | By FUJIFILM Wako Europe GmbH
Watch this webinar to find out how RT-rt PCR is revolutionising sterility testing and discover a unique approach that provides reliable one-day results and enhanced sensitivity and detection capabilities.
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.