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What will shape the future of advanced therapies in Europe?
Following his opening keynote at this year’s Advanced Therapies Europe conference in Barcelona, Professor Jacob George, MHRA Chief Medical & Scientific Officer, explores the evolving regulatory landscape for advanced therapy medicinal products.
ArticleStrategies for scaling complex next-generation biologics
As biologic drug formats grow more sophisticated, scalable success depends on embedding manufacturability, analytics and quality thinking into molecular design from the very beginning of development.
OpinionHow can we ensure consistency in decentralised cell therapy manufacturing?
Following her presentation at Advanced Therapies Europe, Charlotte Serra navigates the complexities of decentralised cell therapy manufacturing.
ArticleRethinking the role of chemotherapy in haematology and oncology – reflections from EHA 2026
As chemotherapy use declines and targeted therapies assume a larger role in cancer treatment, researchers are looking beyond response rates to focus on real-world feasibility and reducing treatment burden for patients.
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NewsEnhanced microbial cultivation method bridges transition between native habitats and the lab
Applying the continuous-flow technology enabled domestication of previously uncultured bacteria, addressing a key bottleneck in laboratory microbial cultivation.
NewsBayer’s Kerendia approved in US as first new CKD and type 1 diabetes therapy in three decades
FDA’s latest approval authorises Bayer’s non-steroidal mineralocorticoid receptor antagonist (MRA) Kerendia for a third indication.
NewsSanofi trims mature medicines portfolio and divests of three manufacturing sites
Divestment agreement expands decade-long collaboration between Sanofi and Cheplapharm, helps to hone Sanofi’s innovation focus.
NewsNovo Nordisk tightens obesity market focus with ‘Novo’ name change
The Danish pharmaceutical giant hopes the strategic rebranding and modernising its culture will sharpen the company’s competitive edge in the rapidly evolving obesity and diabetes therapeutics landscape.
From our partners
The impact of negative control stability on recombinant endotoxin testing
In this webinar, FUJIFILM Wako Chemicals Europe GmbH will present the results of a study evaluating how NC stability in endotoxin detection reagents affects assay performance.
Closing the data integrity gap in pharmaceutical quality control
Pharmaceutical quality control laboratories face growing pressure to strengthen data integrity as regulators scrutinise incomplete records, manual data entry, and disconnected systems.
Opinion and interviews
What will shape the future of advanced therapies in Europe?
Following his opening keynote at this year’s Advanced Therapies Europe conference in Barcelona, Professor Jacob George, MHRA Chief Medical & Scientific Officer, explores the evolving regulatory landscape for advanced therapy medicinal products.
How can we ensure consistency in decentralised cell therapy manufacturing?
Following her presentation at Advanced Therapies Europe, Charlotte Serra navigates the complexities of decentralised cell therapy manufacturing.
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Risks of non-compliance: managing impurity control and challenges with reference materials
Join USP to explore the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
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Ensuring drug quality: mastering stability testing in pharma
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From passive to active air monitoring in aseptic filling: a risk-based approach to replacing settle plates
In this webinar, Particle Measuring Systems will share a case study of a biopharmaceutical company developing and applying a structured global rationale for the implementation of continuous viable environmental monitoring with a single-use microbial impactor within aseptic manufacturing environments.
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The impact of negative control stability on recombinant endotoxin testing
In this webinar, FUJIFILM Wako Chemicals Europe GmbH will present the results of a study evaluating how NC stability in endotoxin detection reagents affects assay performance.
Risks of non-compliance: managing impurity control and challenges with reference materials
Ensuring drug quality: mastering stability testing in pharma
Modernising pharma QA/QC laboratories: preparing for a more connected, compliant future
From passive to active air monitoring in aseptic filling: a risk-based approach to replacing settle plates
The impact of negative control stability on recombinant endotoxin testing
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