In-process and quality controls (IPC/QC) are required for consistent cell manufacturing. Integrated sampling pouches on the CliniMACS Tubing Sets allow for samples to be collected at any time during and at the end of the cell manufacturing process. Miltenyi Biotec provides complete solutions with its MACS Flow Cytometers, a wide portfolio of MACS IVD Antibodies, a time-saving and standardized staining procedure with StainExpress antibody cocktails, and automated flow cytometry analysis with Express Modes for clinical flow cytometry.
When using a MACSQuant® Instrument, Express Modes allow for fully automated and standardized flow cytometry processes. The MACSQuant Instrument and the MACS Flow Cytometry Portfolio are for research use only. MACS IVD Antibodies are produced according to the quality management system ISO 13485.
For the manufacture and use of gene-engineered T cells, national and international legislation and regulations must be followed. The manufacturer has to validate the QC method. Miltenyi Biotec as the provider of products for the T cell engineering does not give any recommendation regarding the use of the manufactured cells for therapeutic purposes and does not make any claim regarding a clinical benefit.
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