Authenticating manufactured human cells for regenerative medicine
Linda Hogle (University Wisconsin-Madison)
Paper short abstract:
Upscaling cell manufacturing entails standardization of processes and cells, yet line specificities must be authenticated to ensure that products are market-ready and commercially valuable. Authentication practices in cell industrial design are analyzed, with unanticipated effects.
Paper long abstract:
As regenerative medicine moves from discovery research to commercial scale-up, quality assurance (QA) and industrial manufacturing processes are applied toward a goal of fabricating a disciplined, standardized, replicable therapeutic tool. More than just creating cost and process efficiencies at scale, the instruments, measurements and technologies involved produce a particular kind of cell—one ready for market and regulatory systems as much as for healthcare. This means cells should be safe, potent, 'controlled,' and with market-driven characteristics. Yet human cells are living, biological entities which change in interaction with environments and conditions throughout all phases of sourcing, expansion and production. Cell phenotyping is thus critical for QA and production processes as well as for market-readiness. This involves particular practices of authenticating cells by source and by characteristics. Authentication-work organizes labor, validates specific administrative technologies, tracks transactions, establishes credibility according to perceived benchmarks, and conveys value in interaction with market demand. Using data from interviews and observations of a large-scale, multi-institutional cell manufacturing consortium, this paper examines processes and practices of authentication as a way to illustrate the unanticipated work that standardization does in an emerging biological industry.
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