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Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
Antibody-drug conjugates (ADCs) are designed to be highly-targeted therapies with the potential to maximise the potency of a treatment while reducing unwanted side effects on healthy tissues. Some 20 years after the first ADC product approval, Dominik Schumacher and Jonas Helma-Smets of Tubulis GmbH discuss how improved and optimised technologies…
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
Here AMR Industry Alliance representatives Melissa Gong Mitchell and Steve Brooks discuss how the Alliance is mobilising the life sciences sector in combatting antimicrobial resistance (AMR). They present the newly established antibiotics manufacturing standard that aims to minimise pharma’s contribution to AMR in the environment, considering the critical considerations and…
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
Alexandre Le Vert, CEO and Co-Founder of Osivax, explores some evolving approaches to vaccine development that aim to counter the effects of virus mutation.
The market for counterfeit pharmaceutical products remains strong, with dishonest actors proving perennially tenacious. Here, Rich Quelch offers guidance on the technologies and practices that are helping to impede fraudsters.
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
Results from several haemophilia trials have been presented at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress 2022, here EPR summarises some of the key developments.
In this article, Andrew Toher, Head of Customer Insights Europe at Enel X, delves into the potential benefits and key considerations of a sustainable energy strategy.
In this Q&A, Bryan Kobel, Chief Executive Officer of TC Biopharm, discusses innovations in cell therapies, introducing the company’s work in gamma delta (γδ) T-cell technologies and his predictions for the future of cell therapy development.
Carl Bjartmar, Chief Medical Officer at Ascelia Pharma, explores the benefits of oral therapeutic administration over intravenous chemotherapy for stomach cancer patients, highlighting improvements in efficacy and ease of use.
With the focus on environmental, social and governance (ESG) issues rising worldwide, in this article, Morgan, Lewis & Bockius LLP Partners, Lesli Ligorner and Louise Skinner discuss the evolving landscape, presenting the emerging regulations for reporting social factors across Asia and Europe.
