ICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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Articles
Adopting AI for R&D in 2025 – what needs to be addressed?
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
Targeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
Investing in the future of pharmaceutical microbiology QC
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products…
Pharma Horizons: Sustainability
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
The EU AI Act: will regulation drive life science innovation away from Europe?
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
Modernising drug delivery through gel-based technology
Julie Huynh, Research and Development Manager, Gelteq, explores the potential of gel-based oral drug formulations for alleviating dysphagia and highlights the company’s approach to overcoming key challenges in this area, like administration.
Curated and customised outsourcing
As the outsourcing market evolves, pharmaceutical businesses are reassessing their strategies to better insulate themselves against the pressure of compounding macroeconomic constraints, including a looming patent cliff, rising costs and developmental risks. Sponsors are adopting more intelligent, blended models that seamlessly integrate functional service provision (FSP), full-service outsourcing (FSO), standalone…
MAS-100 Libra®: the future of continuous cleanroom monitoring
Microbiological monitoring is essential for pharmaceutical facilities. As regulatory standards tighten, especially in cleanroom classes A and B, the need for reliable, continuous monitoring has grown. The MAS-100 Libra meets these demands by combining traditional settle plate methods with advanced automation, improving efficiency and accuracy.
Understanding endotoxin cartridge testing: frequently asked questions
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
The future of media hydration: balanced media in automated single-use platforms
By automating and simplifying hydration of media, feeds and buffers, the Oceo Rover system enables manufacturers of biopharmaceuticals to improve process consistency and speed time-to-market. Here, Guy Matthews, Director of Single-Use Technology for FUJIFILM Irvine Scientific, shares more about this transformative hydration solution.
Environmental Monitoring In-Depth Focus 2024
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
Guide to Outsourcing 2024
In this Guide to Outsourcing article, Jessica Rayser, Associate Director Product Management, Accugenix®, explores how outsourcing microbial identification can benefit technicians and facilitate the most accurate identification possible.
European Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
