news
GSK to acquire Affinivax for MAPS vaccine platform
GSK will pay up to $3.3 billion to acquire Affinivax, gaining access to its Multiple Antigen Presenting System (MAPS) technology and pneumococcal vaccine candidates.
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Drug Safety
news
How can X-ray irradiation advance pharmaceutical sterilisation?
Among several alternative methods, X-ray irradiation is being considered as a potential pharmaceutical sterilisation process. Here, EPR summarises the salient points of a paper exploring why.
news
Mitigating the risks of PPE shortages for compounding pharmacies
Personal protective equipment (PPE) is a critical aspect of environmental and contamination control for compounding facilities, here we look at strategies to overcome PPE shortages.
news
Is FTIR the future of cleaning verification?
Here, EPR explores the application of Fourier Transform Infrared spectroscopy (FTIR) in pharmaceutical cleaning verification.
podcasts
EPR Podcast Episode 11 – Developing vaccine technologies – Giulia Giordano and Mark Doherty, GSK
Why is vaccine manufacturing becoming more biological? How could Generalized Modules for Membrane Antigens (GMMA) enhance vaccinology? What developments have there been in adjuvant systems? Discover all this and more in this podcast with GSK experts.
news
TOC sampling error could be impacting cleaning verification
Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.
news
EMA’s human medicines committee (CHMP) May 2022 meeting highlights
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
news
Emergent destroyed almost 400mn COVID-19 vaccines due to quality issues, finds report
US Government investigation report suggests Emergent Biosolutions destroyed almost 400 million doses of COVID-19 vaccine and worked to conceal quality issues from the FDA.
news
WEVEE vaccine shows promise against trio of rare but deadly viruses
Phase I trial data suggests that a vaccine targeting three mosquito-borne encephalitis viruses is safe and can elicit an immune response.
news
Production of Novartis’ radioligand therapy suspended
Novartis has suspended production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey as it addresses potential quality issues identified in its manufacturing processes.
news
Fenfluramine found effective in preventing drop seizures from LGS
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
article
The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
article
Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
news
EMA’s human medicines committee (CHMP) April 2022 meeting highlights
At its latest meeting, EMA’s human medicines committee (CHMP) recommended the approval of four medicines, seven extensions of therapeutic indication and laid out recommendations for diabetes treatment outside of the EU.
whitepaper
Product hub: The new MAS-100 Atmos® microbial compressed gas sampler makes it simple to sample
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
