QbD for biopharmaceutical product lifecycle management
Youngsun Kim and Busol Park from Samsung Biologics detail the benefits of using a Quality-by-design approach for biologics manufacturing.
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Articles
From pipettes to processors: How AI Is reshaping pharma’s future
The rise of AI, digital twins, and advanced computational modelling signals a paradigm shift in pharmaceutical R&D. These advances are poised to challenge long-standing methodologies, demanding a workforce capable of navigating an evolving technological landscape. Alistair Henry, UCB’s Chief Scientific Officer, examines how the sector needs to embrace the shift…
Regulating decentralised manufacturing in the UK – a legal perspective
Harry Jennings, Partner at VWV, discusses the UK's new framework governing point of care (POC) and modular manufacturing and its implications for manufacturers and marketing authorisation holders in the UK.
Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers
Courtney Soulsby, Sector Development Director, Healthcare at the British Standards Institute, reveals how the industry can prepare for PFAS regulations now to get ahead of the curve.
Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
The key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
AI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
Pharma Horizons: Artificial Intelligence
EPR's latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
The case for immigration concessions: maintaining the UK’s competitiveness in science and technology
Immigration law experts from Fragomen LLP discuss currently challenges in the UK’s visa system and propose recommendations for attracting science and technology talent that support the country’s competitiveness.
European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
Preparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
How could tariffs impact the pharmaceutical industry?
Proposed US tariffs on pharmaceutical imports could disrupt global supply chains, drive up production costs, and exacerbate drug shortages. How will the industry respond?
Innovating bioanalysis to advance oligonucleotide therapeutics
Here, Dr Jinpeng Li at WuXi AppTec reveals the analytical challenges that are hindering advancement of oligonucleotide therapeutics, medicines which have demonstrated clinical promise in the gene therapy space, and discusses promising analytical innovations.
Unlocking intellectual property potential in European pharma
Joshua Harris, Director, Burford Capital, discusses how patent monetisation, including systems like the Unified Patent Court (UPC), enables European pharmaceutical companies to remain competitive and ensure R&D investment and innovation.
Harnessing industry advancements to accelerate upstream process development
Here, Shidong Shi, Head of Upstream Process Development, and Li Yang, Vice President of CMC Development at Altruist Biologics, discuss the key trends in upstream processing and highlight their approach for overcoming challenges in the field.
