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Researchers have developed a novel platform technology, iVAX, that could enable the decentralised bioproduction of conjugate vaccines and enhance vaccination rates in developing nations.
The new draft guidance has recommended dapagliflozin as an option for treating certain people with chronic kidney disease (CKD) in adults.
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.
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…
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…
Digitalised Eppendorf products support customers on their way to a paperless lab whilst in compliance with good laboratory practice (GLP).
The future of sustainable LAL testing has arrived with ACC’s PyroSmart NextGen recombinant LAL reagent technology for bacterial endotoxin testing (BET).
Discover how to improve your microbial identification process, reduce costs and protect your manufacturing process and brand reputation.
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
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.
Researchers have created a new workflow using pepsin to expedite the LC-MS analysis of adeno associated virus (AAV) capsid proteins for gene therapies.
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
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.
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
Alnylam joins the third Grand Challenge (GC3) consortium to help overcome barriers to the manufacture of oligonucleotides.
