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Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
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QA/QC
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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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Supply chain challenges cause Pfizer’s COVID-19 vaccine production target to be slashed
Pfizer spokesperson reveals supply chain challenges and late clinical trial results contributed to its COVID-19 vaccine production target for 2020 being halved.
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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).
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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.
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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.
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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.
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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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Production of hand sanitiser – consideration and tips for manufacturers
The top considerations for hand sanitiser manufacturers in the UK are outlined in this article by Robert Bussey.
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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.
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EMA initiates rolling review of Moderna’s COVID-19 vaccine
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
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WHO lists first vaccine for emergency use
The nOPV2 vaccine has received emergency use listing and will be used to combat outbreaks of circulating vaccine-derived polio viruses (cVDPVs).
