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.

  • Be on the Safe Side with Rapid Sterility Testing: speed, accuracy and efficiency provided by the Microsart® ATMP Sterile Release kits
  • Rapid Real-time PCR Mycoplasma Detection Kit for ATMPs
  • Gain translational insights with cell-based assays for in-process characterization and release testing

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Biosafety & Characterization Solutions

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Microsart® ATMP Sterile Release Kit

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.

  • Validated method
  • Detect a broad range of bacteria and fungi
  • Highest level of qPCR specificity

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Microsart® ATMP Mycoplasma Detection Kit

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.

  • 3 hour time-to-result
  • Designed for ATMP testing
  • Easy handling and highest level of security

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Incucyte® Live-Cell Analysis Platform

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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iQue® Advanced Flow Cytometry Platform

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.

  • Detection Cell-By-Cell 1000s of cells per second
  • Multiple Readouts for every event
  • Natural Conformation of cells and targets

Applications supporting CAR-T therapy product characterization include:

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Benefits of Our Biosafety & Characterization Solutions

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Delivering Rapid Results Ensures Safety

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. 

Predictive Assays

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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Dedicated Advanced Therapies Team

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.

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Resources for Biosafety & Characterization

Application Note

Real-Time PCR-Based Detection of Microbial Contaminations

 Microsart® ATMP kits sensitively detect microorganisms, even in the presence of high-density cell cultures, and reduces risks to patients.

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Microsart® ATMP Mycoplasma Datasheet

Microsart® ATMP Mycoplasma

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.

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T-Cell Exploration and Characterization Compendium

T-Cell Exploration and Characterization Compendium

Compendium of selected key solutions for streamlining T-Cell therapeutic development including biosafety testing and characterization.

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Frequently Asked Questions

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.

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Additional Resources

Cell Therapy CAR-T cell attacking cancer cell

Functional and Phenotypic Assessment

Offers in vitro, cell-based functional and phenotypic assay platforms which enable quantitative and predictive evaluation of key CAR-T cell functions.

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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.

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Cell Therapy Product Characterization Services

Our product characterization services combine rapid PCR, ELISA and custom methods in fully compliant cGMP facilities.

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