Dipl.-Phys.

König, Niels

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  • Publication
    Needle to needle robot‐assisted manufacture of cell therapy products
    ( 2022)
    Ochs, Jelena
    ;
    Hanga, Mariana P.
    ;
    Shaw, Georgina
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    Duffy, Niamh
    ;
    Kulik, Michael
    ;
    Tissin, Nokilaj
    ;
    Reibert, Daniel
    ;
    Biermann, Ferdinand
    ;
    Moutsatsou, Panagiota
    ;
    Ratnayake, Shibani
    ;
    Nienow, Alvin
    ;
    König, Niels orcid-logo
    ;
    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.