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
Biosafety & Characterization Solutions
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
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
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:
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:
- T- Cell Characterization Kit
- Cytokine Profiling
- Cell Health & Proliferation
Benefits of Our Biosafety & Characterization Solutions
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.
Discover Cell Analysis Applications
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.
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.
