Cell Therapy
Be a trailblazer in cell therapy development
“In our search for reliable controls for cell therapy assays, partnering with Slingshot has been a game-changer. Together, we addressed significant challenges by engineering custom CD3 T-cell mimics.”
Amina Kariminia, Ph.D. Immunologist, Analytical Development Scientist,
Fred Hutch Cancer Center
Synthetic cells for Advanced Cell Therapies
How Cells are tested in Cell Therapy Process and the Current Pain Points
Reliable and accurate controls are keystones to ensuring that the processes and test methods used in producing a cell therapy works properly. This is vital for ensuring that cell therapy products are safe, effective, and meet high quality standards. Thus, the cell therapy process deserves the most precise technology available.
Synthetic cells are an innovative approach to support cell therapy testing workflows specifically in the patient characterization, product characterization, and patient monitoring phases. Through catalog products and custom solutions, our platform offers a large array of possibilities for resolving immunophenotyping, bio-translational, and quantitative antigen evaluations.
Slingshot Biosciences’ synthetic cell platform makes creating the right control easier and faster. Our technology offers the flexibility to design controls that precisely match the surface biomarker and optical properties of target cells, with unparalleled reproducibility and shelf-life stability. This innovative approach to testing controls saves time and resources, accelerating your path to clinical trial development and commercial manufacturing.
Synthetic Cells for Patient Characterization
Slingshot’s synthetic cell controls offer consistency, stability, and long shelf life that have enormous benefits over biologically derived controls. These reliable cell surrogates enhance the accuracy and standardization of assays, which are used for analyzing patient biological samples at the start of the cell therapy process. Our technology serves multiple needs at this critical stage:
Synthetic cells precisely mimics CD4+ and CD8+ expression levels
Featured Product: TruCytes Lymphocyte Subset
Synthetic cell controls can precisely match the profile of CD4+ and CD8+ T-cells and more. Achieve the full match of T, B, and NK cells in a single product.
Quality Control
Synthetic cell controls provide a means for continuous quality control checks, ensuring that the assay systems remain sensitive and specific to the cells of interest.
Assay Validation and Performance Check
Synthetic cells can match specific cell characteristics, making them essential for validating flow cytometer performance before analyzing patient samples.
Reproducibility Across Labs
Across multiple labs, synthetic cells can ensure consistent and comparable results across multi-center sites, crucial for the integrity of patient sample analysis.
Training and Proficiency Testing
The predictability of synthetic cells serve as a tool for training and proficiency evaluation of lab personnel, ensuring skillful sample handling and analysis, which upholds result accuracy.
Related Products
Biomarker controls for immunophenotyping of lymphocyte subset populations
Innovative scatter calibrants to standardize flow cytometry instruments
Ready out-of-the box set of controls to enhance training and proficiency
Application Note: A workflow to demonstrate the use of TruCytes Lymphocyte Subset, a synthetic cell for TBNK control reagent
Reliably Characterize Cell Therapy Products
Testing controls play a vital role in the in-process QC (IPC) and final QC stages of the cell therapy process. Especially in the identity assays, positive controls ensure accurate and sensitive detection of surface markers, gene expression, and secreted molecules. Having the right controls ensure that the associated analytical methods are robust, reliable, and most importantly: specific.
Accessing consistent and specific testing controls is not easy. Here are the key roles that synthetic cells can help:
Specific: Key biomarkers, reportable antigens (such as EGFR), and even CAR expression can be “expressed” on synthetic cells to create highly specific controls. This serves as the ideal benchmark against which the cell therapy products can be measured. Working with the Fred Hutch Cancer Center, synthetic cells with EGFR+ surface biomarker became the optimal control for their cell therapy testing.
Quantitative: Unlike cell lines where antigen expression is highly variable, synthetic cells can be engineered with precise density of a desired antigen. The result is a first-of-its-kind control that serves as the actual ground truth for measuring antigen levels such as for BCMA, CD19, PD-L1, and many more.
Consistent: Precise and consistent from batch to batch, synthetic cells solves for the time-consuming quality testing while reducing the high resource burden and the associated documentation headaches.
Reveal More in Patient Monitoring
The patient monitoring phase of the cell therapy process often lacks appropriate controls to measure the persistence and activity of the CAR-T cells (due to low frequency). Quantitative antigen density controls can support this monitoring by providing valuable powerful insights into treatment efficacy, disease progression, treatment optimization, and quality control of clinical samples. For instance, by measuring the number of BCMA or CD19 molecules on patient samples, clinicians can determine if the therapy will be effective at targeting and treating the cancer cells.
Mimic Antigen Levels of Cells
Synthetic Cells with BCMA vs. MM1-S cell line
Simple Path to Real Quantitation
Easily correlate to known quantitative levels of real antigen
Featured Products
Quantitative multilevel of BCMA antigen
Quantitative multilevel of CD19 antigen
Webinar
Flow cytometry is crucial in cell therapy, facilitating the identification of various cell types across the manufacturing spectrum, from initial screening to final product evaluation. Despite advancements, challenges in standardization and data interpretation persist. This presentation will address these challenges and discuss new flow cytometry tools to improve qualification and validation processes.
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