A University of Pittsburgh Medical Center-funded collaborative research initiative by the Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) and the McGowan Institute for Regenerative Medicine has been published in Risk Analysis, the official journal of the Society for Risk Analysis and the highest-ranked journal in the field. The study’s senior author, McGowan Institute for Regenerative Medicine
affiliated faculty member Fabio Triolo, PhD (pictured left), is director of ISMETT’s cell production facility and cell therapy R&D. First authors of the study are Fabio Lopez, management engineer, Dipartimento di Tecnologia Meccanica, Produzione e Ingegneria Gestionale, Università di Palermo, Italy, and Chiara Di Bartolo, research staff coordinator, Ri.MED Foundation. The report was co-authored by Bruno Gridelli, MD, ISMETT director; Tommaso Piazza, ISMETT chief information officer; McGowan Institute for Regenerative Medicine faculty member Jörg Gerlach, MD, PhD (pictured right); and the late Antonino Passannanti, Dipartimento di Tecnologia Meccanica, Produzione e Ingegneria Gestionale, Università di Palermo, to whom the work was dedicated. The report was presented at the 19th annual meeting of the Society for Risk Analysis Europe, held in London in mid-2010. Ms. Di Bartolo delivered the talk on behalf of the group.
The study, “A Quality Risk Management Model Approach for Cell Therapy Manufacturing,” investigates risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine as recognized by international regulatory authorities. Mistakes in cell manufacturing can lead to severe injury or death of patients. Although theoretically accepted as a useful tool for improving process quality, risk analysis still poses several challenges in its practical implementation, especially for those innovative processes in which product quality depends highly on human intervention, and for which common standards of risk acceptability have yet to be defined.
This is the case with cell-based product manufacturing. The report is the first to provide specific risk analysis methods and procedures applicable to the manufacturing of advanced therapy medicinal products (somatic cell therapy, gene therapy, and tissue engineering products). It also is the first to demonstrate the appropriateness of the proposed quality risk management model approach in clinical cell therapy manufacturing. This pilot study describes how the main risk analysis-related challenges faced in a cell-based product manufacturing context — high dependence on human intervention and absence of reference standards for acceptable risk levels — were identified and addressed. It provides guidance to cell-processing facilities by describing the methodology underlying a specific risk analysis approach applicable to clinical cell therapy manufacturing in general.
In this work, the authors accurately identify an unmet need within the emerging areas of cell therapy and regenerative medicine product development related to overall risk management and assessment, extending to the quality of a manufactured cell product. The paper represents an important step in the development of an essential assessment tool that is likely to benefit the field of cell therapy regulatory review and could encourage additional efforts on the part of others in this area.
Illustration: McGowan Institute for Regenerative Medicine.
UPMC International Extra (11/2010)
Abstract (A quality risk management model approach for cell therapy manufacturing. Lopez F, Di Bartolo C, Piazza T, Passannanti A, Gerlach JC, Gridelli B, Triolo F. Risk Analysis. 2010 Dec;30(12):1857-71.)