End-to-end automatic cultivation of adherent stem cells and derivatives from a single instrument
BERGISCH GLADBACH, 14 July 2020 – Miltenyi Biotec announced the immediate availability of its new CliniMACS Prodigy® Adherent Cell Culture System. A flexible architecture specifically developed for the GMP-compliant CliniMACS Prodigy Platform, it enables the automated, scalable, and closed manufacturing of various adherent cell types, including stem cells and their derivatives. Tested processes include, for example, GMP-compliant expansion of human mesenchymal stromal cells, and pluripotent stem cells,as well as differentiation of the latter into dopaminergic progenitors.
The CliniMACS Prodigy Adherent Cell Culture System’s modular nature allows users to build customized and automated manufacturing processes suitable for the culture of adherent cell types in a closed system and a single instrument. This minimizes operator influences and open handling steps, thus increasing product consistency. Meanwhile, it reduces the requirements for high-class cleanroom facilities and manual operations, which represents significant cost savings on cleanroom operations and labor hours. Taken together, the CliniMACS Prodigy Adherent Cell Culture System is capable of meeting the various demands of regenerative medicine, in particular for reliable and cost-effective cell manufacturing to ultimately support cell therapies.
Regenerative medicine has become a key focus of labs and clinics worldwide, and the number of clinical trials using stem cells – especially pluripotent stem cells – is increasing rapidly every year.
Dr. Andreas Bosio, Senior R&D Manager at Miltenyi Biotec commented: “We have learned a lot from cell therapies using hematopoietic stem cells, and more recently CAR-T cells, and are now ready to transfer this knowledge to pluripotent stem cell–based therapies. This system enables routine production of small phase I batches up to mass production of thousands of doses in a ballroom approach. Moreover, the system is flexible enough to be used for experimental optimization of early-stage manufacturing protocols, for example, for new cell types.”
Prof. Dr. Annelise Bennaceur-Griscelli, University Paris Saclay, APHP– CITHERA Inserm UMR 935, found the CliniMACS Prodigy provided a safe and standardized, scalable manufacturing platform for GMP-iPSC master cell banks when using it to provide automated cell feeding and harvesting in a closed system.
The CliniMACS Prodigy Adherent Cell Culture System offers nine modules that automate different workflow steps required for expansion and differentiation of adherent cell types. Flexible combination of these modules, together with full control of the manufacturing parameters, allow for individual, customizable manufacturing workflows to suit a large variety of applications. Cell manufacturing takes place in the fully closed and GMP-compliant CliniMACS Prodigy Tubing Set 730, whilst external culture vessels can be easily connected to bring cell manufacturing to larger scale.
Modules of the CliniMACS Prodigy Adherent Cell Culture System
| Pre-process | Preparation of the system for all subsequent cell culture steps |
| Density gradient | Density gradient centrifugation of primary cell material |
| Coating | Coating of the CliniMACS Prodigy chamber or external culture vessels (ECVs) |
| Inoculation | Seeding of cells in the CliniMACS Prodigy chamber or ECVs |
| Culture | Cell cultivations in the CliniMACS Prodigy chamber |
| Media change | Media change in the CliniMACS Prodigy chamber or ECVs |
| Harvest | Harvest and formulation of the final cell product |
| Deinstallation | Guided step-by-step deinstallation of the tubing set |
| End | Completion of the process |
For further information on the CliniMACS Prodigy® Adherent Cell Culture System and its modules click here.