Results 1 to 10 of about 1,708 (90)

Cell‐Based Biohybrid Micro/Nanorobots for Biotherapy

Advanced Robotics Research, EarlyView.
This review systematically evaluates cell‐based biohybrid micro/nanorobots (CB‐BMRs), highlighting their cell selection criteria, fabrication strategies, and diverse actuation modes. Furthermore, it surveys the promising therapeutic applications of CB‐BMRs in targeted cancer, thrombosis, and inflammation treatments, while comprehensively discussing ...
Lin Wang, Chenlu Liu, Yu Zhao, Chuanhua Li, Xuyang Chen, Shixiao Ding, Lizhou Dai, Guokun Wang, Tianlong Li, Jiaxin Li, Xuejia Liu, Haocheng Wang   +11 more
wiley   +1 more source

Electric Double Layer Engineering Induces O‐Down Interfacial Water Reorientation for Efficient and Long‐Term Seawater Electrolysis

Advanced Energy Materials, EarlyView.
The additive EDTMPS inhibits hydroxides deposition by chelating with Ca2+/Mg2+. It also disrupts the hydrogen bond network of interfacial water and expands the thickness of electric double layer, promoting more free water to flip into adsorbable O‐down configuration.
Tongzhou Li, Yutong Zhao, Hongjie Zhang, Yangkai Han, Zhiwei Ren, Feng Xie, Zongping Shao, Zhigang Shao   +7 more
wiley   +1 more source

Engineering Intelligent iPSC Biomanufacturing: Integrating Robotic Automation, AI, and Process Control

Advanced Intelligent Systems, EarlyView.
This review highlights recent advances in automated iPSC culture systems integrating robotics, advanced imaging, artificial intelligence, and process control. These technologies improve reproducibility, scalability, and quality in cell expansion, differentiation, and real‐time monitoring, while emerging AI‐enabled and closed‐loop approaches offer new ...
Hyoryong Lee, Roma Desai, Byunggik Kim, Deok‐Ho Kim   +3 more
wiley   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?

Biotechnology and Bioengineering, EarlyView.
Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady, Nicholas Donohue, Alexandra Bogdanovic, Sharon Davin, Brian Glennon, Niall Barron, C. Mark Smales   +6 more
wiley   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source