Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapies for untreatable diseases, generating the need for large volumes of high-quality, clinically-compliant GMP cells to replace costly, high-risk and limited scale manual expansion processes. We present the design of a fully automated, robot-assisted platform incorporating the use of multiliter stirred tank bioreactors for scalable production of adherent human stem cells. The design addresses a needle-to-needle closed 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 biological material; all commands are performed through a graphic interface. Seeding of source material, process monitoring, feeding, sampling, harvesting and cryopreservation are automated within the closed platform, comprising two clean room levels enabling both open and closed processes. A bioprocess based on human MSCs expanded on microcarriers was used for proof of concept. Utilizing equivalent culture parameters, the AUTOSTEM robot-assisted platform successfully performed cell expansion at the liter scale, generating results comparable to manual production, while maintaining cell quality postprocessing.


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    Titel :

    Needle to needle robot-assisted manufacture of cell therapy products


    Beteiligte:
    Ochs, J (Autor:in) / Hanga, MP (Autor:in) / Shaw, G (Autor:in) / Duffy, N (Autor:in) / Kulik, M (Autor:in) / Tissin, N (Autor:in) / Reibert, D (Autor:in) / Biermann, F (Autor:in) / Moutsatsou, P (Autor:in) / Ratnayake, S (Autor:in)

    Erscheinungsdatum :

    2022-08-06


    Anmerkungen:

    Bioengineering & Translational Medicine , Article e10387. (2022) (In press).


    Medientyp :

    Aufsatz (Zeitschrift)


    Format :

    Elektronische Ressource


    Sprache :

    Englisch



    Klassifikation :

    DDC:    629 / 670



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