news
NICE recommend dapagliflozin for treating chronic kidney disease
The new draft guidance has recommended dapagliflozin as an option for treating certain people with chronic kidney disease (CKD) in adults.
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Technology
article
Maintaining EU MDR certification: a spotlight on post‑market clinical follow-up
Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
article
Real-time Transition Analysis curve in column chromatography with SIMCA®
Transition Analysis (TA) is a method traditionally used to evaluate the condition and integrity of a chromatography column. However, this method generally requires conducting complex data post‑processing and calculations which are hard to automate and to run in real time during the manufacturing process. Thus, completing the TA offline leads…
article
Continuous biomanufacturing – where are we now?
The biopharmaceutical industry is driven by the need to increase production and reduce costs, while maintaining product quality – and has increasingly been focused on intensification of processes to accomplish this goal. In this article, European Pharmaceutical Review’s Hannah Balfour summarises the potential benefits of implementing continuous bioprocessing and manufacturing…
whitepaper
Product hub: Documentation at your fingertips
Digitalised Eppendorf products support customers on their way to a paperless lab whilst in compliance with good laboratory practice (GLP).
article
Your endotoxin experts
The future of sustainable LAL testing has arrived with ACC’s PyroSmart NextGen recombinant LAL reagent technology for bacterial endotoxin testing (BET).
article
Globally harmonised microbial identification services with Charles River Accugenix®
Discover how to improve your microbial identification process, reduce costs and protect your manufacturing process and brand reputation.
whitepaper
Application note: A new, more flexible endotoxin test platform
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
article
Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
news
Pepsin key for fast and efficient AAV peptide analysis, finds study
Researchers have created a new workflow using pepsin to expedite the LC-MS analysis of adeno associated virus (AAV) capsid proteins for gene therapies.
news
New mass spectrometry technique to detect low-level host cell proteins
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
podcasts
EPR Podcast Episode 4 – UV/Vis in mRNA vaccine QC with Dr Hans-Joachim Muhr, Mettler Toledo
Join Mettler Toledo's Dr Hans-Joachim Muhr as he explains the key quality considerations for mRNA vaccines and why UV/Vis spectrophotometry should be applied in their QA/QC.
news
Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
news
Alnylam joins the Medicines Manufacturing Innovation Centre
Alnylam joins the third Grand Challenge (GC3) consortium to help overcome barriers to the manufacture of oligonucleotides.
news
Mass spectrometry for gene therapy vector analysis
Researchers show combining mass spectrometry and a gas-phase electrophoretic mobility molecular analyser improves detection of full and empty virus-like particles for gene therapies.
