Results 221 to 230 of about 3,202,728 (266)

Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to analyse clinical investigation‐device initial submissions received by the MHRA between January 2022 and December 2025. Methods Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end‐point was submission type.
Andrea Manfrin   +7 more
wiley   +1 more source

The critical role of teacher educators in promoting socially just mathematics teaching

open access: yesBritish Educational Research Journal, EarlyView.
Abstract This paper focuses on the enablers and constraints that shape mathematics teacher educators' agency in addressing social justice issues within their practice and how these can be harnessed or overcome. Given the potential impact of teacher educators on the student/practising teachers they work with, and consequently on the agency of classroom ...
Pete Wright   +8 more
wiley   +1 more source

A Behavior‐Integrated Potency Assay for Quantitative Evaluation of Extracellular Matrix Remodeling by Mesenchymal Stem/Stromal Cells

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT Reliable potency assays are critical for ensuring the therapeutic consistency and manufacturing quality of mesenchymal stem/stromal cells (MSCs). Conventional assays based on soluble factor quantification often fail to capture extracellular matrix (ECM) remodeling capacity and exhibit high variability.
Shao Ying Tan   +2 more
wiley   +1 more source

Isolating T‐Cell Potent Lentiviral Vector Subpopulations through Rational Design of Nanofiber Anion‐Exchange Adsorbents

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT Generation of CAR‐T cell therapies relies predominantly on lentiviral vectors (LVs). As in vivo CAR‐T trials progress, demand for larger quantities of higher‐potency LV is expected. However, primary capture by anion‐exchange chromatography (AIEX) remains a major manufacturing bottleneck from use of adsorbents not tailored to LVs, leading to ...
George Pamenter   +10 more
wiley   +1 more source

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

open access: yesBiotechnology 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   +2 more
wiley   +1 more source

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