Needle to needle robot‐assisted manufacture of cell therapy products

Abstract 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...

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Main Authors: Jelena Ochs (Author), Mariana P. Hanga (Author), Georgina Shaw (Author), Niamh Duffy (Author), Michael Kulik (Author), Nokilaj Tissin (Author), Daniel Reibert (Author), Ferdinand Biermann (Author), Panagiota Moutsatsou (Author), Shibani Ratnayake (Author), Alvin Nienow (Author), Niels Koenig (Author), Robert Schmitt (Author), Qasim Rafiq (Author), Christopher J. Hewitt (Author), Frank Barry (Author), J. Mary Murphy (Author)
Format: Book
Published: Wiley, 2022-09-01T00:00:00Z.
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042 |a dc 
100 1 0 |a Jelena Ochs  |e author 
700 1 0 |a Mariana P. Hanga  |e author 
700 1 0 |a Georgina Shaw  |e author 
700 1 0 |a Niamh Duffy  |e author 
700 1 0 |a Michael Kulik  |e author 
700 1 0 |a Nokilaj Tissin  |e author 
700 1 0 |a Daniel Reibert  |e author 
700 1 0 |a Ferdinand Biermann  |e author 
700 1 0 |a Panagiota Moutsatsou  |e author 
700 1 0 |a Shibani Ratnayake  |e author 
700 1 0 |a Alvin Nienow  |e author 
700 1 0 |a Niels Koenig  |e author 
700 1 0 |a Robert Schmitt  |e author 
700 1 0 |a Qasim Rafiq  |e author 
700 1 0 |a Christopher J. Hewitt  |e author 
700 1 0 |a Frank Barry  |e author 
700 1 0 |a J. Mary Murphy  |e author 
245 0 0 |a Needle to needle robot‐assisted manufacture of cell therapy products 
260 |b Wiley,   |c 2022-09-01T00:00:00Z. 
500 |a 2380-6761 
500 |a 10.1002/btm2.10387 
520 |a Abstract 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. 
546 |a EN 
690 |a automation: bioreactors 
690 |a cell therapy 
690 |a human stem cells 
690 |a manufacturing 
690 |a Chemical engineering 
690 |a TP155-156 
690 |a Biotechnology 
690 |a TP248.13-248.65 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
655 7 |a article  |2 local 
786 0 |n Bioengineering & Translational Medicine, Vol 7, Iss 3, Pp n/a-n/a (2022) 
787 0 |n https://doi.org/10.1002/btm2.10387 
787 0 |n https://doaj.org/toc/2380-6761 
856 4 1 |u https://doaj.org/article/8d664c132f564d2da30264fa84d60be3  |z Connect to this object online.