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Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need to ensure data integrity in life sciences. She explains how data integrity can reduce costs and increase patient safety across five key areas: reproducibility, IDMP, the microbiome, semantic enrichment, artificial intelligence and machine learning.
The use of proprietary vaccine constructs to prime naive CD8+ T-cells via skin dendritic cells and thus enable induction of targeted cellular immunity, establishing tissue-resident CD8+ T-memory cells, is a new vaccination strategy being explored at Emergex Vaccines. Here, Professor Thomas Rademacher, Emeritus Professor of Molecular Medicine – UCL and…
Handling highly potent active pharmaceutical ingredients (HPAPIs) or drug product in a laboratory requires implementation of strict security measures. Here, Elodie Barrau and Olivia Jones discuss high potency product handling procedures to ensure continued safety.
With cardiovascular disease continuing to present a significant health concern, European Pharmaceutical Review’s Hannah Balfour reflects on recent development efforts and drug approvals in the space with comment from Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.
Sebastian Stachowiak, Head of Europe & GCC at Global Blood Therapeutics (GBT), explains how, while the company establishes its presence in Europe, it continues its commitment to advance the care of people living with sickle cell disease by collaborating with the sickle cell community to develop breakthrough therapies, raise awareness…
Targeted protein degradation (TPD) therapy has grown rapidly as a field, with transformational potential. TPD is poised to be successful in delivering marketed products, but limitations are now starting to emerge, including tumour resistance, a lack of mechanisms for oral dosing, and the inability to penetrate tissues such as the…
The landscape of biopharmaceutical manufacturing is changing, with complex molecules such as bi-specific antibodies (bsAbs) becoming increasingly prevalent. bsAbs are a large, structurally diverse family of molecules designed to recognise two targets and globally there are over 230 in development as promising therapies for cancer and other diseases. While they…
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
Cleanroom and laboratory managers need to collaborate to set their employees up for success. They must also be willing to review their procedures even when it seems an employee is responsible for an error.
Features in this in-depth focus highlight the opportunities presented by targeted protein degradation therapeutics, as well as the breakthroughs in developing treatments for sickle cell disease.
