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Title: A meta-analysis of biological variation in blood-based therapy as a precursor to bio-manufacturing
Authors: Thurman-Newell, Jamie A.
Petzing, Jon N.
Williams, David J.
Keywords: Biological variation
Process design
Quality control
Issue Date: 2016
Publisher: Elsevier (© International Society for Cellular Therapy)
Citation: THURMAN-NEWELL, J., PETZING, J. and WILLIAMS, D., 2016. A meta-analysis of biological variation in blood-based therapy as a precursor to bio-manufacturing. Cytotherapy, 18 (5), pp.686-694.
Abstract: 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. A systematic meta-analysis of the medical literature surrounding HSCT has been completed of which the key outcomes are the following: (i) the range of transplanted CD34+ cells/kg can be up to six orders of magnitude around the median for allogeneic procedures and four orders of magnitude for autologous procedures, (ii) there is no improvement in variation encountered over a period of 30 years and (iii) as study size increases, the amount of variation encountered also increases. A more detailed, stratified source from a controlled single-site clinical center is required to further define a control strategy for the manufacture of biologics.
Description: This paper was accepted for publication in the journal Cytotherapy and the definitive published version is available at http://dx.doi.org/10.1016/j.jcyt.2016.01.011
Sponsor: Funding for this work was provided by the UK Engineering and Physical Sciences Research Council (Grant EP/FS00491/1) as part of the Doctoral Training Centre for Regenerative Medicine.
Version: Accepted for publication
DOI: 10.1016/j.jcyt.2016.01.011
URI: https://dspace.lboro.ac.uk/2134/21083
Publisher Link: http://dx.doi.org/10.1016/j.jcyt.2016.01.011
ISSN: 1465-3249
Appears in Collections:Published Articles (Mechanical, Electrical and Manufacturing Engineering)

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