Biosafety & Characterization
Ensuring the safety of patients receiving CAR-T Cell therapy already begins in the Research and Development phase and advances through the production of clinical grade materials where validated test methods for microbiological quality control - as well as characterization testing - need to be in place. As the timeline between product manufacture, release and patient administration is short, rapid testing solutions are required.
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Validated test results for Advanced Therapy Medicinal Products (ATMPs): Rapid bacteria and fungi detection in only 3 hours.
The combination of speed, accuracy and efficiency provided by the Microsart® ATMP Sterile Release kits means ATMP manufacturers can deliver QC results prior to treatment. In doing so, the industry stands to eliminate one of the outstanding risks to patients posed by ATMP, thereby setting the stage for the use of consistently safe lifesaving cell-based therapies.
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Microsart® ATMP Mycoplasma utilizes quantitative, real-time polymerase chain reaction (qPCR) as the method of choice for sensitive and reliable detection of mycoplasma contamination in autologous cell transplant cultures.
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Continuous, real-time live-cell imaging and analysis providing more biologically and physiologically relevant insights.
Live-cell assays supporting CAR-T therapy product characterization include:
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Advanced flow cytometry with the iQue® platform provides a robust, high-throughput solution for multiplexed studies of T cells.
Combined with four of our T cell characterization kits (iQue® Human T Cell Activation Kit, iQue® Human T Cell Killing Kit, iQue® Human T Cell Exhaustion Kit, and iQue® Human T Cell Memory Kit), they collapse the traditional workflow by providing a convenient approach for evaluating cell phenotypes, T cell markers, cell proliferation, cell viability and secreted cytokines, to be measured in a single sample.
Applications supporting CAR-T therapy product characterization include:
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Rapid Detection of Mycoplasma, Bacteria and Fungi in Just Three Hours
Microsart® Mycoplasma, Bacteria & Fungi qPCR kits offer rapid, reliable and easy-to-use solutions for microbial contamination control in compliance with international guidelines.
Sartorius in vitro, live-cell based assays provide quantitative and unbiased measurements which can be translated into clinical outcomes and enable the development of better-characterized products to patients.
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Our Dedicated Advance Therapies Team provide solutions that help immune cell therapy developers and manufacturers accelerate their time to market and lower their COGs. These solutions are specifically designed to address the unique challenges and goals of CAR-T R&D, process development and manufacturing.
Contact us today to discuss how we can support your CAR-T Research & Development project.
Microsart® ATMP kits sensitively detect microorganisms, even in the presence of high-density cell cultures, and reduces risks to patients.
A standard DNA extraction followed by a TaqMan® probe real-time qPCR is used for the detection of Mycoplasma DNA with results in 3 hours.
Compendium of selected key solutions for streamlining T-Cell therapeutic development including biosafety testing and characterization.
The Incucyte® AI Cell Health Analysis Software Module is an all-in-one analysis tool that segments cells and classifies them as live or dead. It allows users to increase throughput of cell health analyses, characterize adherent or non-adherent cells without the need for fluorescent labels, generating accurate and objective data with reduced time requirements and cost.
Offers in vitro, cell-based functional and phenotypic assay platforms which enable quantitative and predictive evaluation of key CAR-T cell functions.
Microsart® Mycoplasma, Bacteria & Fungi qPCR kits offer rapid, reliable and easy-to-use solutions for microbial contamination control.
Our product characterization services combine rapid PCR, ELISA and custom methods in fully compliant cGMP facilities.
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