whitepaper
Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
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Vaccines
whitepaper
Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
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mRNA-1010 quadrivalent flu vaccine shows promise in Phase I study
Moderna's quadrivalent flu vaccine mRNA-1010 boosted titres against all four strains 29 days after vaccination in young and older adults.
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Technical note: The content of nevirapine and related impurities
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
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Brochure: Simplify your compliance process
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
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FDA authorises Evusheld for COVID-19 prevention
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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Application note: Impurity analysis of L-aspartic acid and glycine
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
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Whitepaper: Sterility testing – difficult products
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
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Sanofi to acquire Origimm Biotechnology to develop acne vaccine
Sanofi has entered into an agreement to acquire Origimm Biotechnology to add a potential first-in-class vaccine for acne to their pipeline.
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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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Whitepaper: Accelerate biologics development via innovation
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.
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Press release: Freeze drying: New Telstar Usifroid platform for retrofitting & maintenance
Telstar launches Usifroid global service platform for retrofitting & maintenance of freeze-dryers. To optimise and extend the life cycle of freeze-drying equipment from any brand or model.
