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Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
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.
EPR discusses the findings of a recent study exploring whether microbicidal treatments using radiation cause the degradation of crude herbal medicinal components.
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.
28 July 2022 | By Thermo Fisher Scientific
Watch this webinar as we discuss how to successfully leverage software capabilities to enhance the scientific experience for your laboratory and laboratory personnel.
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
This whitepaper shares how analytical solutions from METTLER TOLEDO can be used to characterise COVID-19 vaccines.
Ex-MHRA inspector and NSF expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters in this online introduction training.
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-300x278.jpg)
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-e1657792683882.jpg)
The voluntary US-wide recall of Lot DX9067 of Propofol Injectable Emulsion, USP is due to the possible presence of visible particulate with potentially harmful effects.
Here, EPR summarises a paper that asks whether cleanroom sanitisation procedures are adequate, discussing the emerging problem of microbial resistance to disinfectants.
Here, EPR summarises the microbial contamination concerns that may arise from aging facilities presented in an article by Tim Sandle.
Cold chain shipping challenges & root causes of common reference product sourcing problems.
