Functional CAR-T Discovery & Development Services: Optimizing Therapeutic Efficacy

Why Functional Profiling Matters in CAR-T Development

Chimeric Antigen Receptor T (CAR-T) cell therapies have revolutionized treatment paradigms for hematologic malignancies, yet their translation to solid tumors and broader indications remains constrained by functional limitations. Despite exhibiting strong antigen binding, many CAR-T candidates fail due to insufficient cytotoxicity, premature exhaustion, poor in vivo persistence, or off-target toxicities. These challenges highlight a critical reality: antigen affinity alone does not predict therapeutic efficacy—functional performance does.

Recent publications have emphasized that functional markers such as cytokine polyfunctionality, resistance to the immunosuppressive tumor microenvironment, and memory T cell persistence are tightly correlated with clinical outcomes. Therefore, robust functional evaluation is not only a scientific necessity but also a regulatory and clinical imperative. At Creative Biolabs, our Functional CAR-T Discovery and Development Services are built to meet this challenge head-on, bridging the gap between promising in vitro constructs and real-world therapeutic impact.

Fig.1 The timeline of the development of CAR T cell therapy.¹

At Creative Biolabs, we understand that the clinical success of CAR-T cell therapies depends not only on antigen specificity, but increasingly on functional performance. As CAR-T research moves toward solid tumors, allogeneic platforms, and next-generation constructs, functional attributes—such as cytotoxicity, cytokine secretion, persistence, and exhaustion resistance—are pivotal for therapeutic efficacy and safety.

To help our partners accelerate functional validation and optimization of their CAR-T candidates, we offer a comprehensive Functional CAR-T Discovery and Development Service Platform. This fully integrated suite of solutions includes:

Each component is designed to capture critical performance indicators across the CAR-T development continuum—from early discovery to preclinical validation—enabling smarter, faster, and more predictive therapeutic design.

Key Features of Our Functional CAR-T Services

Creative Biolabs combines high-resolution analytics with cutting-edge immunoengineering to extract meaningful functional data that drive translational success. Our services are uniquely defined by the following:

Integrated Multi-parameter Assays: We measure cytotoxicity, cytokine polyfunctionality, and activation/exhaustion profiles (PD-1, LAG-3, CD69, TIM-3) concurrently, aligning with recent findings on multi-cytokine secretion as a biomarker of durable response.

Serial Tumor Rechallenge Models: Mimicking clinical tumor recurrence scenarios, we evaluate T cell persistence and functional recall—key correlates of long-term remission in patients.

Customizable SynNotch and Logic-Gated CAR Designs: Enabling antigen-specific control to minimize on-target/off-tumor effects, validated in accordance with recent innovations in switchable CAR logic circuits.

Metabolic Fitness Profiling: We assess mitochondrial function, glycolytic rates, and reactive oxygen species (ROS) levels—emerging determinants of T cell exhaustion and performance in solid tumor environments.

Humanized In Vivo Models: Utilizing NSG and MISTRG mice reconstituted with human immune components to evaluate efficacy, expansion, and safety of CAR-T cells in vivo.

Why Creative Biolabs

Unlike general service providers, Creative Biolabs distinguishes itself through the following scientific and operational strengths:

• Our team has developed over 300 CAR constructs targeting diverse antigens and co-stimulatory domains. We maintain an internal library of pre-validated constructs, spacers, and intracellular motifs (e.g., CD28, 4-1BB, ICOS, OX40), allowing rapid iteration and construct refinement based on functional outcomes.
• We utilize in-house developed multi-well CAR-T and target co-culture systems, paired with real-time impedance-based cytotoxicity readers and custom flow cytometry panels. These tools allow simultaneous assessment of killing kinetics, exhaustion, and cytokine output from hundreds of clones—critical for screening large CAR-T libraries.
• Our bioinformatics division integrates transcriptomic (bulk and single-cell RNA-seq), proteomic, and metabolomic data, enabling clients to trace phenotypic outcomes to molecular signatures. For example, we correlate transcriptional signatures of T cell stemness with in vivo expansion capacity, in line with clinical data.
• We offer access to humanized xenograft models and CAR-T trafficking studies using bioluminescent imaging, allowing preclinical validation of therapeutic efficacy, cytokine release risk, and tumor regression over time.
• All assays are performed under stringent SOPs with GLP-aligned data packages available for IND-enabling studies. We provide raw data, statistical reports, and graphical visualizations to support regulatory filings or investor documentation.

Partner With Us

In the evolving CAR-T landscape, function is the new frontier. Creative Biolabs offers the tools, experience, and scientific insight to ensure your CAR-T candidates are more than antigen binders—they are clinically actionable therapies.

Whether you're initiating a discovery campaign or refining a lead candidate, our functional CAR-T discovery and development services will bring the clarity and confidence needed for your next milestone.

Contact us today to design a custom solution that empowers your CAR-T program with true functional precision.

Reference

1. Mitra, Aroshi et al. "From bench to bedside: the history and progress of CAR T cell therapy." Frontiers in immunology vol. 14 1188049. Distributed under Open Access License CC BY 4.0, without modification.