For example, the STAR system (Hamilton) is only able to pipette small volumes at a time (5 mL), while the Ambr15 system is limited by the minimum agitation speed that can be employed (and hence minimum local energy dissipation rates), thus limiting its applicability. Key considerations include the level of particulates, the potential of leachates and extractables, and the integrity of seals and connections.

The mantra in cell therapy manufacturing states that “the product is the process.” That is especially the case with insufficient process characterization data.
2016, 2019). © 2020 Springer Nature Switzerland AG. Cell and gene therapies typically rely on patient or donor cells as starting material for their manufacture which determines significant batch-to-batch variation inherent to the complexity of the biological product (Heathman et al. A company’s choice of technology can depend on the process duration and scale as well as the type of operation. The timing of operations is important to control during process scale-up and automation.


For example, is it critical that pH be monitored or controlled — or only the concentration of carbon dioxide? Operators must decide whether to count cells on the grid borders and whether cells have taken in the dye. volume 41, pages1245–1253(2019)Cite this article. Are you ready to take the next step towards realizing your therapy's commercial potential. 2016). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Google Scholar, Lipsitz YY, Timmins NE, Zandstra PW (2016) Quality cell therapy manufacturing by design. However, similarly to the CliniMACS Prodigy, this platform is also limited to the CAR-T cell space and has not been tested for adherent cell culture (Iyer et al. Even when stringent protocols are used, variation is observed between different handlers as a result of minor imprecisions in protocols (e.g. Reliance on custom equipment significantly increases both the capital investment and the time required to design and build that equipment. slight deviations in incubation times, variation in pipetting etc.). This inevitably makes control, reproducibility and repeatability of this kind of bioprocesses challenging. So if the product will be cryopreserved, then its cryoprotectant components will need to be concentrated in the cryoprotectant solution and account for salts and sugars in the elutriation buffer to ensure that osmolality is controlled. In this respect, better process monitoring could accelerate process development and improve production efficiency, while ensuring high-quality endpoint products (Rodrigues et al. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion. Process Understanding and Design Enable Effective Automation: The type of automation used in manufacturing cell therapies depends on the cell types involved and the technology used to isolate, expand, and purify them, as well as the type of final container used. the bone marrow) is also performed automatically as the bone marrow suction device is integrated into the platform. This platform is essentially a hollow fibre bioreactor that contains single-use cartridges, providing a surface area of 2.1 m2 per cartridge (Iyer et al. A company’s ability to implement an automation strategy depends on its degree of process knowledge and in-house understanding of how critical process parameters (CPPs) relate to critical quality attributes (CQAs) under the quality by design (QbD) paradigm. In the cell and gene therapy realm, the benefits of automation could be translated into closed manufacturing platforms. The existing platforms will be discussed in the next sections where they are categorised depending on the level of automation integrated. different process conditions or different cells). (Lindgren et al. This is important as the field is continually evolving and the added complexity of bioprocesses using living cells will always be there, as biological processes are far from being understood or predicted to the same extent as chemical processes currently are (Jung et al.


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