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Start Over Author "Larson, Ryan P." Publisher elsevier bv
5 results on '"Larson, Ryan P."'

2. Developing patient-centric specifications for autologous chimeric antigen receptor T cell therapies

Author

Larson Ryan P, Nolan Polson, Kedar Dave, Taylor Zhang, and Heidi Zhang

Subjects
Product design specification, Computer science, T cell, media_common.quotation_subject, Biomedical Engineering, Medicine (miscellaneous), Bioengineering, Computational biology, Commercialization, Chimeric antigen receptor, Biomaterials, medicine.anatomical_structure, Patient centric, medicine, Quality (business), In patient, Product (category theory), media_common
Abstract

With an increasing number of clinical developments and commercial launches of autologous chimeric antigen receptor T-cell therapies, appropriate specification strategies throughout the development lifecycle are critical to ensuring product safety, quality, and patient access on commercialization. A unique aspect of autologous chimeric antigen receptor T-cell therapies is the individualized nature of this class of drug. The heterogeneity in patient leukapheresis material and its impact on drug product quality must be considered in developing a risk-based product specification. This review describes a framework for establishing a patient-centric specification based on correlative analysis linking product attributes with clinical outcomes, variance component analysis deciphering the sources of variability, and appropriate statistical analysis of clinical lot release data.

Published
2021

4. Antigen Availability Shapes T Cell Differentiation and Function during Tuberculosis

Author

Moguche, Albanus O., primary, Musvosvi, Munyaradzi, additional, Penn-Nicholson, Adam, additional, Plumlee, Courtney R., additional, Mearns, Helen, additional, Geldenhuys, Hennie, additional, Smit, Erica, additional, Abrahams, Deborah, additional, Rozot, Virginie, additional, Dintwe, One, additional, Hoff, Søren T., additional, Kromann, Ingrid, additional, Ruhwald, Morten, additional, Bang, Peter, additional, Larson, Ryan P., additional, Shafiani, Shahin, additional, Ma, Shuyi, additional, Sherman, David R., additional, Sette, Alessandro, additional, Lindestam Arlehamn, Cecilia S., additional, McKinney, Denise M., additional, Maecker, Holden, additional, Hanekom, Willem A., additional, Hatherill, Mark, additional, Andersen, Peter, additional, Scriba, Thomas J., additional, and Urdahl, Kevin B., additional

Published
2017
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