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Guide to Outsourcing & Testing

26 October 2022 | By

In this Guide to Outsourcing & Testing, EPR explores trends in the pharmaceutical outsourcing market. Plus, Charles River discusses solutions for tracking, trending and microbial identification and Associates of Cape Cod International showcases its endotoxin testing capabilities.

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Using design of experiments to optimise SEC method conditions for proteins

24 October 2022 | By

Size exclusion chromatography (SEC) is routinely used in the pharmaceutical industry to characterise the higher and lower molecular weight species proteins. Here, Gregory Webster, Senior Principal Research Scientist in Analytical Research and Development at AbbVie, explores the challenges, opportunities and optimisations needed to execute design of experiment studies to project…

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Pharma’s green mission: trends in bacterial endotoxin testing

21 October 2022 | By , , , ,

Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.

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Methods for strain comparison and differentiation of environmental isolates

21 October 2022 | By

Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…

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Microbiology In-Depth Focus 2022

19 October 2022 | By

Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…

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European Pharmaceutical Review Issue 5 2022

17 October 2022 | By

In EPR Issue 5, articles explore the role of whole genome sequencing in pharmaceutical microbiology, the formulation of oral taxanes and the potential for tackling immune-mediated disease with CAR T regulatory cells. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing and much…