Summer 2022 haemophilia trial update
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.
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Articles
Sustainable energy strategies for pharmaceutical manufacturers
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.
Advancing cell therapies – γδ T cells and the combination factor
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.
Novel oral chemotherapeutic holds potential for stomach cancer patients
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.
ESG considerations in Europe and Asia: social inclusion – the new diversity frontier in life sciences
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.
Staying abreast of regulations with NGS‑based viral safety for faster, safer and more ethical lot release of our vaccines
Here, Sridhar Pennathur, Vice President, Analytical Development at Novavax, highlights the value of next generation sequencing in their vaccine production operations by answering key questions.
Five areas in life sciences where data integrity is vital
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.
Anatomy of a ‘correlate of protection’ for T-cell vaccines
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…
The challenge of handling highly potent API and ADCs in analytical chemistry
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.
Developing a holistic approach to cardio, metabolic and renal disease
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.
Global Blood Therapeutics: driving innovation in sickle cell disease
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…
Pursuing new paths in targeted protein degradation drug development
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…
Rapid method development to overcome challenges of bi-specific antibody purification
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…
2022 spells change for EU pharmaceutical legislation
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…
Nitrosamine drug substance-related impurities (NDSRIs)
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
