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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.
Here, EPR explores the application of Fourier Transform Infrared spectroscopy (FTIR) in pharmaceutical cleaning verification.
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.
Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.
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.
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.
Phase I trial data suggests that a vaccine targeting three mosquito-borne encephalitis viruses is safe and can elicit an immune response.
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.
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).
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.
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.
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.
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
Disulphide bonds between cysteines play a critical role in the stability and activity of therapeutic antibodies. Here, Dr Ioannis Papayannopoulos, Principal Scientist at Dragonfly Therapeutics, describes the characterisation of the oxidation state of cysteines and formed disulphides in therapeutic antibody drugs.
The results indicate that mRNA-1273.211 at the 50 µg dose level induced higher antibody responses than the 50 µg mRNA-1273 booster, even when additional variants of concern were not included in the booster vaccine.
