Flow cytometry can be put to excellent use for in-process and quality control (IPC/QC) testing in the field of cell and gene therapy. As no other system on the market has met our high quality and functional requirements, Miltenyi Biotec has developed its, highly automated MACSQuant® Analyzer. It is designed for use in GMP-compliant cell manufacturing environments, with bespoke analytical features to provide precision and maximum flexibility.
Determination of incoming product phenotype and composition, as well as evaluation of cellular identity and purity of final CGT products for release testing, are easy with our MACSQuant Analyzer. Our operating software offers an ‘Express Mode’ module which allows fully automated sample acquisition, data analysis, and reporting. It can also streamline analytical features such as calibration, compensation, and staining, and even harmonize instrument settings across multiple devices and sites to meet relevant GMP requirements, irrespective of operator. Designed and built from long-standing experience in developing instruments and protocols for cell analysis, it is hands-down the best way to optimize manufacturing workflows when used in combination with the CliniMACS Prodigy® Platform.
Standardizing flow cytometric assays in cell manufacturing faces significant challenges from variability along the workflow. A complete solution to this problem must address three main sources of disagreement: variability across flow cytometer instruments, operators, and reagent lots . If your flow cytometry partner can’t fix these issues, demand better! Ready to standardize your flow cytometry assays?
Over more than three decades, we have established numerous protocols for cell analysis during cell manufacturing, as well as cell-based assays. This wide portfolio of verified protocols is also a great basis for efficiently developing new protocols according to your specific requirements. Rounding the offer out, we provide access to an extensive antibody portfolio and accessories to accelerate the development.
All cell analysis protocols established on the MACSQuant Analyzer can be easily scaled up and transferred from one instrument to another for comparable, standardized results, and multi-instrument alignment during inter-lab collaborations or multi-center clinical trials. Our GMP-compliant protocols are verified for commercialization, clinically-proven, and 21 CFR Part 11 supportive.