Orthogonal approach and critical quality attributes for gene and cell therapy products
Introduction: Gene and cell therapy (GCT) products are revolutionizing medicine because they are made up of unique biological components like genetic material, viral vectors, and viable cells.
Ekaterina V. Melnikova +3 more
doaj +1 more source
Modelling stem cell differentiation related processes—A practical overview for biologists
Stem cell differentiation is complex and difficult to control experimentally. This review introduces suitable computational modelling approaches that can support stem cell research, from mechanistic ODE and abstract models to multiscale and deep learning methods.
Ricco Zeegelaar +4 more
wiley +1 more source
The 5′Cap is a modified nucleotide structure added to the 5′end of mRNA, which plays a critical role in stability and translation of the molecule. Accurate characterization of 5′Cap impurities is crucial during development of mRNA therapeutics.
J. Hutchinson +14 more
doaj +1 more source
Design and analysis strategies for robust microbiome ageing research
The gut microbiome changes with age and associates with age‐related morbidity and mortality, establishing it as a potential biomarker and intervention target for ageing. Realising this potential requires methodological rigour, yet distinguishing biological signals from methodological artefacts remains challenging across cohorts. This review provides an
Mark Olenik +5 more
wiley +1 more source
Cyclical quality assurance of examinations is critical but causality needs to be attributed carefully [PDF]
The work of Khafagy and colleagues, reported in this issue, is a reminder of the need to undertake quality assurance activities for high stakes examinations, including the individual items that make up the examination. Quality assurance provides evidence to the candidates taking the examination, and to those who rely on its results, of its validity and
openaire +2 more sources
Investigating transcription factor dynamics in health and disease using FRAP
FRAP analysis of GFP‐tagged transcription factors reveals how molecular mobility and target engagement change in response to drug treatment. By combining live‐cell imaging, quantitative model fitting, and statistical analysis, this approach uncovers transcription factor dynamics linked to disease mechanisms, providing a powerful framework for ...
Kannan Govindaraj +3 more
wiley +1 more source
Conserved binding mode but diverse interfaces of MreC‐PBP2 interactions
The crystal structure of abMreC reveals a conserved two β‐barrel architecture and provides structural insights into its role within the bacterial elongasome. The abMreC–abPBP2 complex model identifies the molecular basis of MreC‐mediated PBP2 recognition, contributing to the regulation of peptidoglycan synthesis.
Hyunseok Jang +4 more
wiley +1 more source
Microbiome‐blood–brain barrier interactions in aging — mechanisms and therapeutic potential
Aging reshapes the gut microbiome (↓SCFA‐producing commensals; ↑pro‐inflammatory outputs), shifting circulating metabolites (↓SCFAs; ↑LPS, ↑TMAO, ↑PAA) that act at the BBB to increase nonspecific transcytosis, alter transport, and promote astrocyte reactivity, heightening brain vulnerability.
Daniel Cuervo‐Zanatta +3 more
wiley +1 more source
GUEST SERVICES QUALITY ASSESMENT IN TOURISM, USING AN ATTRIBUTES SCALE [PDF]
It is considered that a weakness of the Romanian tourism offer is the quality of guest services. In this paper we established as an objective to examine in detail the importance given by the consumers to the components of guest service quality and their ...
POPA LUMINITA, BAN OLIMPIA
core
The Identification of Critical Quality Attributes (CQAs) for the Development of Antibody Drugs
In the development of quality biopharmaceutical drugs, it is the level of knowledge gained, not the volume of data, which provides the basis for science-based submissions and their regulatory evaluation [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q8 (R2)].
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