Cell and gene therapy resources

Industry experts share insights, best practices and the latest trends to assist you.

Webinar
Be more closed-minded

The significant costs for manufacturing autologous cell therapies continue to create a major barrier to bringing these impactful medicines to more patients. This is primarily due to open process manipulations that require expensive engineering controls and extensive expenses for labor, equipment, materials, cleaning, validation, and a facility footprint. Join industry experts for this timely and important discussion on the use of a fully closed system design that enables commercial scale manufacturing in both centralized and point-of-care settings, and implementation in existing GMP environments.

Webinar
Lentiviral vector development & manufacturing: an established platform process

Developing a cell therapy product is incredibly complex. Speed to clinic and market are imperative to reduce overall costs and maintain competitive market advantages. Leveraging an established lentiviral vector (LVV) process accelerates drug product development. Miltenyi Bioindustry’s LVV platform provides turnkey solutions for cell therapy developers. scalable preclinical batches, validated release assays, a fast-track to GMP manufacturing, and regulatory support.

Webinar
Analytical method development for cell and gene therapy

Given the criticality and often underestimated role of analytics to address clinical and commercial manufacturing requirements, Miltenyi BioIndustry created centers of excellence focusing on analytics that work hand-in hand with process development and technology transfer groups using Miltenyi’s industry-leading cell processing and lentivirus manufacturing platforms.

White paper

Validation of an impedance-based in vitro potency assay for repeatability and intermediate precision
by Danielle Califano1, Jianjie Jiang2, Dirk Windgassen2, Caitlyn De La Flor2, Stacie Chvatal1, Denise Sullivan1, and Daniel Millard1
1Axion BioSystems, Inc., 2Miltenyi Biotec, Inc.

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.

Cell therapy scientific poster

Unlocking potential: Innovative Transduction for CAR γδ T Cell Therapy 
by L. Pinot, N. Möker, J. V. Hidalgo

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.

Interview

Cell and gene therapies demand a robust system 
with Kitman Yeung, MSAT analytical manager, Miltenyi Bioindustry

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.