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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    Title :

    Needle to needle robot-assisted manufacture of cell therapy products


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

    Publication date :

    2022-08-06


    Remarks:

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


    Type of media :

    Article (Journal)


    Type of material :

    Electronic Resource


    Language :

    English



    Classification :

    DDC:    629 / 670



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