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Early, cross-functional Analytical Target Profile (ATP) planning – combined with locked hardware, software, and reagent platforms – turns assay validation into a smooth, predictable process. Miltenyi Bioindustry’s ASAT team standardizes gating, auto-aligns instruments with Smart Gain, and uses StainExpress™ panels to cut repeats and accelerate IND timelines.
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A clinical-stage biotech company leveraged Miltenyi Bioindustry’s robust LVV platform to rapidly transition from preclinical development to GMP production. This case study showcases how a standardized, flexible process with built-in regulatory support can accelerate timelines, reduce risk, and ensure consistent, high-yield outcomes.
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Discover how Miltenyi Bioindustry helped a biotech company enhance a bicistronic CAR construct by improving sequence stability and transduction efficiency. This case study highlights the power of molecular optimization and LVV platform integration to overcome recombination risks and accelerate clinical readiness.
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Discover how Miltenyi Bioindustry helped automate and optimize an autologous cell therapy process, enhancing scalability, reducing contamination risks, and ensuring clinical trial readiness. This case study highlights innovative solutions that streamline complex workflows for regulatory and clinical success.
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This white paper demonstrates the validation of an impedance-based potency assay for CAR T cells, showing high repeatability and precision across replicates, operators, and days. Using the Maestro Z™ platform, the assay accurately quantifies CAR T efficacy in a real-time, non-invasive manner, supporting reliable immunotherapy product evaluation.
By Danielle Califano1, Jianjie Jiang2, Dirk Windgassen2, Caitlyn De La Flor2, Stacie Chvatal1, Denise Sullivan1, and Daniel Millard11Axion BioSystems, Inc., 2Miltenyi Biotec, Inc. | Download whitepaper
Explore an innovative feeder cell–free protocol for efficient expansion of Vγ9Vδ2 T cells following αβ T cell depletion, coupled with high CAR transduction efficiency using the BaEV pseudotype and Vectofusin®-1. The integration of CAR constructs further amplifies the natural cytotoxicity of Vγ9Vδ2 T cells, demonstrating a clinically viable approach within closed systems like the CliniMACS Prodigy® for scalable production.
By L. Pinot, N. Möker, J. V. Hidalgo | Download scientific poster
CGT experiments are complex and require high standards for approval and translation into routine clinical use. Read how you can use software, tools such as the MACSQuant® Analyzer, and the tips provided here to save time, reduce potential problems, and improve the results of your CGT experiments.
With Kitman Yeung, MSAT analytical manager, Miltenyi Bioindustry | Download interview