Cell Therapy CAR-T cell attacking cancer cell

Advanced Technologies to Support Next-Generation CAR-T Cell Therapies

Advanced Technologies for Research & Discovery of CAR-T Cell Therapies

Chimeric antigen receptor (CAR) T-cell therapy represents a major advancement in the fight against cancer and a paradigm shift toward personalized medicine. Although treatment with CAR-T cells has produced remarkable clinical responses within certain subsets of B-cell leukemia or lymphoma, many challenges limit the therapeutic efficacy of CAR-T cells in solid tumors. 

This rapidly growing field faces several challenges, from basic research and early-stage clinical trials to Investigational New Drug (IND) applications and final product release.  These challenges include comprehensive screening of the product as well as quality control testing to ensure patient safety. 

Additional challenges in research and development of effective CAR-T cell therapies include:

  • High cost and technical difficulty of phenotyping, profiling and purifying immune cells
  • Difficulty in engineering and characterizing CAR-T cells with improved anti-tumor activity and decreased toxicity
  • Controlling variability to ensure comparability of experiments
  • Reliability of conventional assays on suspension cells or 2D cell monolayers which lack many of the complex cell-cell and cell-ECM interactions found in vivo

Sartorius addresses these challenges with cutting-edge solutions that streamline lab-scale research and development workflows for characterizing quality attributes of T-cells.

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CAR-T Cell Therapy Research & Development workflow
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Applications Covered in CAR-T Research & Development

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CAR Construct Design and Screening

In vitro cell-based and protein interaction assays support early-phase CAR-T research and discovery

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Function and Phenotyping Assessment

Measure biomarker phenotype, tri-lineage differentiation capacity, viability, exhaustion and killing efficacy with iQue® and Incucyte® systems

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CAR-Vector Preparation and Testing

Lab-scale lentivirus workflow and quality testing solutions

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Biosafety & Characterization

Analytical characterization and microbial safety testing are critical pillars of patient safety

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Sartorius Solutions for CAR-T Research & Development

Incucyte®️ Live-Cell Analysis Platform

The Incucyte® Live-Cell Analysis Platform enables real-time, live-cell analysis directly inside your incubator. Measure kinetic effects of your cell viability and characterize phenotypic or functional changes of CAR-T target cells without ever having to remove cells from the incubator. Incucyte® software makes the process of acquiring, viewing, analyzing and sharing images of living cells easier than ever before. 

  • Cell-based assays are now the gold standard used by researchers for information-rich objective analysis of in vitro cell models, specifically when evaluating complex diseases or therapies
  • Fast-track your scientific discovery by combining lab-tested protocols and reagents with powerful, information-rich analysis supported by specific Incucyte® software modules
  • Study immune-cell function, movement, and morphology quickly and with exceptional reliability, reproducibility
  • Assess function of modified T cells in complex co-cultures, 2D or 3D models

Related eBook: Harnessing the Power of T Cells

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iQue® Advanced Flow Cytometry Platform

The iQue® Advanced Flow Cytometry Platform is a high-throughput, suspension cell and bead analysis platform for rapidly profiling of immune-cell phenotype and function in therapeutic workflows. Ideal for those screens where cells are precious or limited in number, the iQue® is the fastest way to generate high-content data from small samples. 

Microfluidics acquisition capability analyses samples as small as 10 μL in a 384-well format, with zero dead volume. Cell detection occurs at rates of thousands of cells per second.

  • Obtain multiple readouts for every event
  • Maintain the natural conformation of cells and targets
  • Study complex 2D or 3D cell models using advanced flow cytometry; perform CAR-T cell analysis-based workflows as a translational approach to in vitro characterization of immunotherapies
  • Simultaneously quantify secreted cytokine levels and immune cell function within the same sample
  • Detect T-cell response in 3D tumor spheroids, using advanced flow cytometry and live-cell analysis combined platforms

Related App Note: Combining Live-Cell Analysis and High-Throughput Flow Cytometry to Gain Additional Insights into the Mechanisms of Immune Cell Killing of Tumor Cells

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Octet® BLI is an easy-to use, real-time analytical tool that rapidly screens critical quality attributes.

Octet® Label-Free Bio-Layer Interferometry (BLI) Detection Platform

Octet®️ Label-Free Bio Layer Interferometry (BLI) technology uses optical biosensors to measure protein-protein interactions in parallel, without the use of detection agents. This robust and fluidics-free approach enables fast, real-time characterization of expressed proteins, even in complex and unpurified samples.  

  • Perform affinity screening of CAR constructs
  • Rapidly determine product titer and binding kinetics
  • Monitor native states label-free and in real time 
  • Quantify and screen CAR-vector potency and access to target binding
  • Characterize antibody-antigen binding kinetics and affinity, bispecific testing, or titer analysis for protein expression, all in one high-throughput, easy-to-use system
  • Recover sample plates after non-destructive measurement

Related White Paper: Streamlining Affinity Analysis for Accelerated Lead Screening

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CellCelector Automated Cell Selection and Retrieval Platform

The CellCelector Flex Platform is a fully automated cell imaging and picking system developed for screening, selection and isolation of single cells, clusters, spheroids, and organoids as well as single-cell clones and adherent colonies.

  • Automated clone ranking and selection of single cells with integrated monoclonality and viability assessment
  • Faster cell selection workflow with reduced wait times for traditional growth and productivity measures
  • Perform clonal passaging of stem cells and stem cell colonies or isolate specific parts of a stem cell colony
  • 100% selective clone recovery without cross-contamination
  • Requires just one plate per cloning experiment, resulting in significant cost savings on consumables, media and incubator storage space
  • Automated selection or characterization of CAR-vector production (LV, AAV) for efficient CAR-T construct creation
  • Monitor plasmid transfection and production or T-cell transduction

Related App Guide: Fully Automated Image-Based Single Cell and Colony Picking for Stem Cells

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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

Related Infographic: Be on the Safe Side

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T Cell and Immunotherapy Media

  • Serum-free, xeno-free media optimized for T cell, TIL, CAR-T, and PBMC applications
  • Excellent performance without the addition of human serum
  • Manufactured in compliance with cGMP guidelines

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 T Cell Preclinical & GMP Growth Factors and Cytokines

  • Animal-derived component-free
  • Purity ≥95%​
  • Available as preclinical- and GMP-grade

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Why Choose Sartorius for CAR-T Research & Development?

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Accelerate Time to Results

Streamlined workflows through collapsing of cell and biomolecule interaction analysis assays, validation of results by complementary technologies and robust multiparametric software analysis.

Obtain results for sterility in only three hours with real-time PCR Microsart® ATMP Sterile Release Kits.

Information-Rich In Vitro Assays 

Multifactorial results of high-content functional and phenotyping assays provide better insight into the desired characteristics of lead product variants, allowing confident selection of products to move forward.

Enhanced Patient Safety

Ensure patient safety through regular testing for microbial contaminants, including mycoplasma, bacteria and fungi throughout your research workflow. Microsart® real-time PCR assays provide rapid results within a few hours and need only a small number of precious samples from small batches.

Resources for Cell Therapy Research & Development

Featured Educational Resources

Incucyte® 21 CFR Part 11 Software Module

Secure and configurable software module to track all system events and user actions.

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Phenotypic and Functional Characterization of CAR-T Cells white paper
White Paper

Phenotypic and Functional Characterization of CAR-T Cells

Learn about streamlined in vitro assays used for phenotyping and functional assessment of modified CAR-T cells, with three case studies.

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Challenges and Solutions in CAR-T Discovery and Development

Download this infographic to learn how CAR-T therapy works, the CAR-T therapy discovery and development steps and more

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Frequently Asked Questions

The iQue® Human T Cell Activation and iQue® Human T Cell Killing kits are compatible with the iQue® Advanced Flow Cytometry Platform and can be used to characterize and monitor the function of T cells. Furthermore, other Qbeads/cytokines and immunophenotyping kits are available to help  isolate T-cells and capture the secreted cytokines level using a high-throughput platform, in the same assay plate. 

The Incucyte® Live-Cell Analysis system enables you to visualize and quantify immune cell interactions and proliferation in real time and automatically generate kinetics data of cell cultures. Scientists can investigate the mechanisms of immune cell activation (proliferation), regulation and differentiation (clustering) from inside the incubator and without the need to perturb or label cells.

The Incucyte® Live-Cell Analysis System and iQue® Advanced Flow Cytometry Platform can be used to evaluate and quantitate key functions of T cells, including activation and clustering, antibody internalization assays, chemotaxis, cytokine production and evaluation of complex co-culture models.

Using the Octet® Label-Free Bio-Layer Interferometry (BLI) Detection Systems, you can quantify and screen CAR-vector potency and access to target binding in cell therapy models and immune cell cultures. 

The CellCelector Flex platform is a fully automated cell imaging and picking system developed for the screening, selection and isolation of single cells, clusters, spheroids and organoids, as well as single-cell clones and adherent colonies.

Detect bacterial and fungal contamination within three hours using the proven real-time PCR method in our Microsart® ATMP Sterile Release Kit, a combination of Microsart® ATMP Bacteria and of Microsart® ATMP Fungi.

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