2134/25346
Jamie A. Thurman-Newell
Jamie A.
Thurman-Newell
Quantification of variation in biological input materials and its effect on manufacture and process control
Loughborough University
2017
Biological variation
Blood
Haematology
Biological manufacturing
Metrology
Quality assurance
Biometrology
Biological metrology
Mechanical Engineering not elsewhere classified
2017-06-09 16:16:27
Thesis
https://repository.lboro.ac.uk/articles/thesis/Quantification_of_variation_in_biological_input_materials_and_its_effect_on_manufacture_and_process_control/9542444
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.