whitepaper
Whitepaper: Analyte binding to syringe filters
Validation of syringe filters for QC testing: The parameters that influence analyte binding to filters.
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QA/QC
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European Pharmacopoeia adopts a new chapter for the analysis of N-nitrosamine impurities
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
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Lonza’s MODA-EM™ Paperless Solution to be implemented at the UK’s New Vaccines Manufacturing and Innovation Centre
The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) has selected Lonza’s MODA-EM™ Solution to digitise its Microbiology Quality Control operations. The MODA EM™ Platform will form a vital part of ongoing work that will support the VMIC coming online a year ahead of schedule.
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Hackers target COVID-19 vaccine cold chain, IBM finds
A group of hackers has sent phishing emails to various people involved in COVID-19 vaccine cold chain distribution to gain insight, IBM has revealed.
whitepaper
Whitepaper: Tips to improve SEC for mAbs and ADCs
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
whitepaper
Whitepaper: Single-use systems underline the rising significance of extractables and leachables studies
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
whitepaper
iPDF: Pharma analysis & QC interactive detailed workflow
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
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EMA begins rolling review of Janssen’s COVID-19 vaccine candidate
The European Medicines Agency's CHMP has started a rolling review of Ad26.COV2.S, Johnson & Johnson's COVID-19 vaccine.
article
Pharma cold chain: is our industry ready, willing and scalable?
The pharmaceutical cold chain includes numerous participants – David Lewandowski discusses why this must be scalable to ensure efficient delivery of a COVID-19 vaccine.
news
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.
whitepaper
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.
news
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.
article
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.
whitepaper
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.
whitepaper
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
