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.