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Exploring the gene therapy biomanufacturing landscape

5 October 2023 | By

In this exclusive Q&A with European Pharmaceutical Review, Sheila Ann Mikhail, co-founder of AskBio and keynote speaker at CPHI Barcelona delves into the current landscape and future potential of the gene therapy sector. She explores strategies for making gene therapies more affordable and accessible, innovations in drug delivery, as well…

The European Commission proposals – what practical impact?

29 September 2023 | By

The European Commission has published its much-anticipated proposed revisions to the EU pharmaceutical legislation. While not as extensive as some had anticipated, with elements such as the supplementary protection certificate – the demise of which has been foretold for years – continuing albeit in a different form, Elisabethann Wright, Partner,…

Considerations for safety data migration methods

26 September 2023 | By

Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.

The benefits of mass spectrometry for expediting biologics to patients

20 September 2023 | By , ,

A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk product…

Implementing the future of mRNA therapeutics

12 September 2023 | By

Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.