More bioprocessing and biomanufacturing – Page 2
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Article
Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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ReportPharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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ArticleBreaking down silos - how digital tools can transform pharma manufacturing
Following their recent LinkedIn Live, Hexagon’s Adam Cross, Industry Director for Pharma and Life Sciences, reveals the state of data in pharmaceutical manufacturing, the opportunities available and how companies can ensure success and sustainable outcomes in their digitalisation journey.
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ArticleSupporting the pharmaceutical industry – how a CDMO can help
After their recent webinar, European Pharmaceutical Review’s Head of Content Ian Betteridge spoke with the team at Adragos Pharma to discuss the role of a CDMO and their importance in the fill and finish sector.
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ArticleA rapid microbiological method case study for advanced therapy medicinal products
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.
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ArticleAlliance for impact - advancing CGT development in Europe
Cell therapy expert Lindsay Davies, PhD, FHEA, discusses the key considerations for moving the needle to broader adoption of CGTs in Europe.
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ReportStreamlining European expansion for cell and gene therapies
Tom Smith, Strategic Director, Cell and Gene Therapies, Uniphar, discusses the essential elements biotechs need for commercial success in Europe’s unique market when developing cell and gene therapies (CGTs).
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ReportBioprocessing / Bioproduction In-Depth Focus 2025
This in-depth focus features articles on biosimilars and biomanufacturing in Europe, the potential of plant tissue-based bioproduction and utilising digital twins for optimisation of bioprocesses.
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PublicationEuropean Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
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ArticleNew biosimilar pathways – key takeaways from the EMA’s draft reflection paper
Gain insight on the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
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ArticleEngineering scalable iPSC-NK therapies
Stefan Braam, Chief Technology Officer, Cellistic, explores the manufacturing and regulatory challenges of scalable, off-the-shelf iPSC-NK cell therapies.
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ReportPharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
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ArticleMeasuring AI’s impact on the pharmaceutical industry
In this article, Updesh Dosanjh, Practice Leader, Pharmacovigilance Technology Solutions, IQVIA, explores how the pharmaceutical industry and its workforce can truly leverage the potential of artificial intelligence (AI) and measure the impact of this technology.
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ReportPharma Horizons: the future of cell and gene therapy
This exclusive report addresses the key challenges and breakthroughs shaping the future of cell and gene therapy, from QC and analytical development to advanced manufacturing strategies. Discover practical solutions you can implement to drive progress for your organisation.
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ArticleQualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
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ArticleAI-driven biomanufacturing: revolutionising production and quality in pharmaceuticals
This article explores how artificial intelligence (AI) is forming an essential pillar of staying competitive in pharmaceutical manufacturing, with its adoption ensuring greater efficiency of medicine production in this fast-evolving sector.
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ArticleQbD 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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ArticleRegulating 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.
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ArticleNavigating 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.
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ArticleBeyond 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.