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Mass customization of cellular therapies for regenerative medicine - impact of regulation and technology

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


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Humans are genetically unique and therefore express diseases and respond to medical treatments differently. Regenerative Medicine offers the best possible outcome for a range of chronic diseases, through the use of personalized therapeutic cellular treatments (i.e. autologous treatments). The personalization of cellular therapies conforms with Pine’s definition of mass customization; the mass production of individually customized goods and services. We use case study research design to explore the complex operational issues surrounding the mass customization of cellular therapies. There has been increasing interest by biotechnology companies and regulators in technologies that allow laboratory and manufacturing processes to be performed in small-scale, modularized ‘closed’ environments. Empirical data from technology providers has shown that their equipment can automate many laboratorial production processes and capture information required for quality control. These innovative technologies allow manufacturing to be decentralized without sacrificing quality. Further improvement in flexibility and speed are critical for cellular therapies as such therapies can be highly perishable and difficult to transport. The regulators’ response has been to grant exceptions for autologous therapies (products) through Excluded Goods Orders, shifting responsibility for patient safety to the attending physician. Early results are mixed, but indicate that biotechnology companies and clinical practitioners have been able to innovatively expand their operations in the healthcare market to move from a small scale to a mass scale customization model. This paper offers an insight into how innovative regulation and technology can be mutually supportive in the business of mass customized cell therapies. However, the consequences in terms of patient outcomes, safety and public trust remain an area of concern.

Publication metadata

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

Editor(s): Grubbstrom, RW; Hinterhuber, H;

Publication type: Conference Proceedings (inc. Abstract)

Publication status: Published

Conference Name: 18th International Working Seminar on Production Economics

Year of Conference: 2014