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Title: Quantification of variation in biological input materials and its effect on manufacture and process control
Author: Thurman-Newell, Jamie A.
ISNI:       0000 0004 6493 9500
Awarding Body: Loughborough University
Current Institution: Loughborough University
Date of Award: 2017
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Currently cellular therapies, such as hematopoietic stem cell transplantation (HSCT), are produced at a small scale on a case-by-case basis, usually in a clinical or near-clinical setting. Meeting the demand for future cellular therapies will require a robust and scalable manufacturing process that is either designed around or controls the variation associated with biological starting materials. Understanding variation requires both a measure of the allowable variation (that does not negatively affect patient outcome) and the achievable variation (with current technology). The prevalence of HSCT makes it an ideal case study to prepare for more complex biological manufacturing with more challenging regulatory classifications.
Supervisor: Not available Sponsor: EPSRC
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available
Keywords: Biological variation ; Blood ; Haematology ; Biological manufacturing ; Metrology ; Quality assurance ; Biometrology ; Biological metrology