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Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
EPR summarises research into the impact of gamma irradiation and ethylene oxide sterilisation treatments on European Pharmacopoeial compliance of common ophthalmic APIs.
Here, EPR presents a novel loop-mediated isothermal amplification (LAMP) assay developed to enable the rapid and sensitive detection of Burkholderia cepacia complex (BCC) in pharmaceutical manufacturing.
This whitepaper shares how analytical solutions from METTLER TOLEDO can be used to characterise COVID-19 vaccines.
Cold chain shipping challenges & root causes of common reference product sourcing problems.
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
With demand for biopharmaceuticals rising and advances being made in bioseparation systems, the global market it expected to witness significant growth.
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
Study shows AEX-MS enables the analysis of IgG4 Fc deamidation variants and, as IgG4 antibodies become more popular, could become increasingly valuable for antibody charge heterogeneity characterisation.
Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
