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Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
In the wake of the UK’s agreed deal with the EU, Andrew Howard, Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, offers advice to those life sciences businesses navigating the transition to a new regulatory landscape.
Kirsten Axelsen and Rajini Jayasuriya of Charles River Associates explore a framework for ethical COVID-19 vaccine allocation in the US.
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
Our video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
Pfizer and BioNTech have agreed to supply the European Union with 200 million additional doses of COMIRNATY in 2021, making the total 500 million doses.
Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…
Effective supply chain management can cut costs, improve service and enhance company revenues; however, the pharma industry has historically been a slow adopter of leading-edge practices. Nikki Withers discussed the fundamentals of contemporary supply chain management with Ed Sweeney, Professor of Logistics and Systems at Aston University, who believes that…
Pharmaceutical counterfeiting brought to the fore, as more than 3,000 saline filled vials being sold as COVID-19 vaccines were seized in Chinese police raids.
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
Through COVAX, doses of the Pfizer-BioNTech vaccine will be provided at a not-for-profit price for 92 low- and lower-middle-income countries.
The global stockpile will provide developing countries responding to Ebola outbreaks with doses of the approved single-dose Ebola vaccine, rVSV∆G-ZEBOV-GP, live, free of charge.
Around 2,000 workers critical to the UK COVID-19 vaccine supply chain will be offered inoculations against the novel coronavirus.
Japan has procurement deals with half of the companies leading the COVID-19 vaccine development race, according to GlobalData.
