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Mass customization of cellular therapies: challenges from a new industry

Lookup NU author(s): Dr Peter O'Neill, Professor Christian HicksORCiD

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Abstract

Humans are genetically unique. They express diseases and respond to medical treatments differently. Personalised cellular therapies (CTs) are a form of mass customization that require the production and delivery of individualised treatments and services. There has been increasing interest by regenerative medicine firms and regulators in technologies that allow laboratory-based manufacturing processes to be operated in small, scalable, modularized ‘closed’ environments. This paper investigates the influence of product development on the feasibility of mass customization strategies in terms of: i) quality, safety and consistency; and ii) the cost of quality. The research used a multiple case study design with two consortia involved in trials of personalised CTs that use a patient’s own cells (autologous therapies). The findings suggest that clinical development using innovative capital equipment can improve the feasibility of CTs by automating laboratory processes, capturing quality data, and reducing costs. This facilitates the decentralised manufacture of autologous CTs and allows horizontal scaling without sacrificing quality. One consortium reduced the cost of quality and human error, whilst the second also improved product yield. The research highlights the necessity of concurrent product and process development, operations strategy and early multidisciplinary supplier involvement in the clinical development of mass customized CTs.

Publication metadata

Author(s): Teng CW, O'Neill P, Hicks C, Sohal A

Editor(s): Missbauer H; Tang O

Publication type: Conference Proceedings (inc. Abstract)

Publication status: Published

Conference Name: Twenty-first International Working Seminar on Production Economics

Year of Conference: 2020

Online publication date: 24/02/2020

Acceptance date: 22/11/2019

Publisher: Universität Innsbruck

URL: https://www.uibk.ac.at/wipl/productioneconomics2020/

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