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Alzheimer’s treatment lowers tau by nearly 50 percent in Phase I trials
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
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QA/QC
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Case study: RMM for identifying contamination sources
See how a leading biopharma company used an RMM analyser in parallel to plate counts to find the root cause of periodic bioburden excursions in its water system.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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Case study: 7000RMS & process control strategy
Learn how Mibelle Group improved their process control strategies using the 7000RMS analyser in parallel with validated plate counts.
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Whitepaper: Cleaning validation
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
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Whitepaper: Learn about biofilm in hot WFI
This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
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Rabbit pyrogen test to be replaced by European Pharmacopoeia
The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
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Nitrosamines: the latest position
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
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Understanding your cleanroom fungi is key, says expert
New data shows that the majority of fungal genera isolated from a GMP cleanroom are filamentous and likely transferred into the facility from outside.
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Global sterilisation monitoring market to value $913mn by 2027
Market research suggests the biological indicators segment will retain the largest share of the global sterilisation monitoring market through 2027.
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Technical bulletin: An updated approach to E&L testing per ISO 10993-18:2020
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
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Pharmaceutical QC market to value $9,700mn by 2027
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.
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British pharma’s 2021 Code of Practice now in force
The ABPI’s 2021 pharmaceutical industry Code of Practice aims to increase transparency, encourage collaboration and improve patient care.
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Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
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Automating microbial methods for data integrity in the modern age
“Continuous improvement” is a buzz phrase in the biopharmaceutical industry. Despite its reference in numerous regulatory and guidance documents, resistance to improvement remains strong in microbiological quality control.
