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Needle to needle robot‐assisted manufacture of cell therapy products
Fraunhofer-Gesellschaft
2022
,
Ochs, Jelena
,
Hanga, Mariana P.
,
Shaw, Georgina
,
Duffy, Niamh
,
Kulik, Michael
,
Tissin, Nokilaj
,
Reibert, Daniel
,
Biermann, Ferdinand
,
Moutsatsou, Panagiota
,
Ratnayake, Shibani
,
Nienow, Alvin
,
König, Niels
,
Schmitt, Robert
,
Rafiq, Qasim
,
Hewitt, Christopher J.
,
Barry, Frank
,
Murphy, J. Mary
Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapiesfor untreatable diseases, generating the need for large volumes of high-quality,clinically-compliant GMP cells to replace costly, high-risk and limited scale manualexpansion processes. We present the design of a fully automated, robot-assistedplatform incorporating the use of multiliter stirred tank bioreactors for scalable pro-duction of adherent human stem cells. The design addresses a needle-to-needleclosed process incorporating automated bone marrow collection, cell isolation,expansion, and collection into cryovials for patient delivery. AUTOSTEM, a modular,adaptable, fully closed system ensures no direct operator interaction with biologicalmaterial; all commands are performed through a graphic interface. Seeding of sourcematerial, process monitoring, feeding, sampling, harvesting and cryopreservation areautomated within the closed platform, comprising two clean room levels enablingboth open and closed processes. A bioprocess based on human MSCs expanded onmicrocarriers was used for proof of concept. Utilizing equivalent culture parameters,the AUTOSTEM robot-assisted platform successfully performed cell expansion at theliter scale, generating results comparable to manual production, while maintaining cellquality postprocessing.