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16 September 2022 | By GenScript ProBio
Learn how to develop an analytical control strategy for different plasmid DNA product applications with GenScript ProBio, a global CDMO in cell and gene therapy industry.
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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…
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.
Here AMR Industry Alliance representatives Melissa Gong Mitchell and Steve Brooks discuss how the Alliance is mobilising the life sciences sector in combatting antimicrobial resistance (AMR). They present the newly established antibiotics manufacturing standard that aims to minimise pharma’s contribution to AMR in the environment, considering the critical considerations and…
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.
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
A new study demonstrates the design and potential of adding artificial components to bacteria to enable tumour targeted drug release and immune activation.
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
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.
Study reveals that different Bacillus strains sporulate better in different media and conditions, establishing optimal parameters to produce spores for disinfectant efficacy studies.
Here, EPR summarises Tim Sandle's review of different methods for transferring items into aseptic areas, including decontamination chambers and pass-through hatches.
