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EDQM releases updated pharmacopoeial quality standards for vaccines
To aid COVID-19 vaccine developers, the EDQM has released an updated European Pharmacopoeia that can be accessed for free.
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Brochure: How to identify and avoid contaminants in LC-MS
In this technical brochure, you will learn some tips on identifying LC-MS contaminants and avoiding contamination.
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EDQM releases new guidelines for COVID-19 vaccine quality testing
The European Directorate for the Quality of Medicines & Healthcare has announced three new guidelines outlining how to test the quality of COVID-19 vaccines.
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Digital agility and customer-centricity – imperatives for Medical Affairs in a post-COVID world
Mary Alice Dwyer and Sameer Lal explain how pharmaceutical companies can embrace a more customer-centric approach through digital transformation.
Whitepapers/App Notes/Posters
Interactive PDF: Risk mitigation and quality requirements interactive tool
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
Whitepapers/App Notes/Posters
Whitepaper: BPOG extractables data in single-use systems adoption
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this webinar taking place on 9 December, we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021. Reserve your free virtual seat today!
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Lack of skill and talent biggest challenge to digital transformation in pharma
A report has found that the biggest hurdle for digital transformation in pharma is a lack of specific skills and talents, followed by organisational silos.
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Differences in remdesivir efficacy due to trial variances, not drug, report says
After remdesivir showed little effect against COVID-19 in the SOLIDARITY trial, a new report has suggested this is due to the structure of the study.
webinar
Uncover the potential of your lab – discover how digital transformation can be so much more than just insights
6 November 2020 | By IDBS
Join our virtual roundtable panel where we discuss best practices and experiences of digital transformation, as well as exploring how digital transformation can help accelerate decision making, optimise processes and remove operational inefficiencies.
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IDMC recommends modifications to Regeneron COVID-19 antibody trial
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
Whitepapers/App Notes/Posters
Fact sheet: TOC monitoring efficiency quiz
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
article
Improving fungal ID options
This article explores a novel method for fungal identification. A case study is presented which showed this method was superior to the reference method with increased identification rates and lower misidentification.
article
Primary validation of the growth direct bioburden system and media
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
article
Solid-state NMR spectroscopy of drug substances and drug products
Solid-state NMR spectroscopy is an effective technique for the analysis of both crystalline and amorphous pharmaceuticals, both in the drug substance and drug product. In this article, Eric Munson provides an overview of the technique and how it applies to pharmaceutical analysis.