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From quantum to clinic: AI reshapes clinical trials
The burden of conducting clinical trials is a significant hurdle in drug discovery. Here, Dr Mark Lambrecht reveals the technological developments that are driving shifts in this space.
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Technology
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WuXi Biologics partners with HanchorBio on next-gen immunotherapies
The CRDMO will support the biotech company’s work on next-generation immunotherapies for oncology and autoimmune diseases.
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Advanced manufacturing research supports automated production of critical API
Study highlights potential of novel system for continuous, automated production of albuterol sulfate, an API on the US FDA’s drug shortage list.
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EMA and FDA issue joint AI guidance for medicine development
The regulators’ 10 principles aim to support pharma companies with evidence generation and monitoring for new medicines.
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AI framework could enhance continuous manufacturing, say FDA researchers
Digital twin model offers potential for advanced control during continuous pharmaceutical manufacturing processes.
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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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Novartis chromatography study shows downstream purification benefits
The impurities research illustrates an approach that could offer a simpler and more flexible downstream purification process.
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Bicycle Therapeutics strikes uranium deal for sustainable radiopharmaceuticals
UK biotech commits to scale up of 228Th extraction and a long-term supply agreement to facilitate production of thousands of doses of 212Pb for cancer therapies annually.
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Nanexa collaboration to enhance Moderna’s mRNA drug delivery
Moderna’s $500 million deal with Nanexa will focus on improving long-acting injectable drug delivery, potentially improving mRNA medicines.
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A careful calibration: balancing small molecule needs and biologic innovation
CDMOs weigh up how to meet manufacturing demands across oral solid doses, monoclonal antibodies, ADCs and beyond.
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Could a simple handle change your cleanroom contamination risk?
MBV AG addresses challenges in air monitoring and aseptic handling with MAS-100 Sirius®: a next‑generation active microbial air sampler created in close collaboration with pharmaceutical manufacturers and cleanroom experts.
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HEATMOS filter technology for depyrogenation tunnels – innovations for extreme conditions
Nippon Muki demonstrates the performance advantages of its innovative HEPA filter for the sterilisation of injectable containers in pharmaceutical manufacturing.
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European Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
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Novel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
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Innovative antibiotic-free method could limit biofilm formation
The proposed mechanical antibacterial approach offers a new way to use metal-organic frameworks, a Nobel Prize-winning material.
