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Advance T Cell Engagers for Precision Immunotherapy

Proprietary T Cell Cytotoxicity Reporter Cell Lines Accelerate Development

WuXi Biologics’ proprietary T cell-dependent cellular cytotoxicity (TDCC) reporter cell lines overcome the structural complexity of T-cell engagers (TCEs) to advance precision immunotherapies. Ready for TCE development, the technology produces mechanism of action (MOA)-reflective data, speeds early development, and supports global regulatory submissions.

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Start faster with licensed access to proprietary, ready-to-use cell banks.

Reduce costs through stage-based licensing.

Enhance sensitivity to detect low-affinity TCEs.

Reflect CD3–CD28 co-stimulation to strengthen immune activation.

What TDCC Is and Why It Matters

A TDCC assay measures a TCE’s ability to activate T cells and kill target cells in vitro. Unlike traditional binding-only assays, TDCC reflects how a therapeutic functions in a relevant biological model. The model meets regulatory expectations for functional data and provides insight into clinical relevance, improving decision-making.

The effector (T cell) and target (cancer cell) combine
The therapeutic binds to CD3 and the target antigen
An immune synapse forms
T cells exert a cytotoxic effect
The assay quantifies target cell killing or T-cell activation

Well-designed controls ensure assay specificity, so the therapy destroys intended targets while sparing healthy cells.

WuXi Biologics’ TDCC cell line enables a host of applications.

Low-affinity TCEs that traditional binding assays cannot detect

Programs needing data matched to MOA

Next-generation TCEs requiring CD3–C28 co-stimulation

Studies seeking the functional data that regulatory agencies prefer

WuXi Biologics’ TDCC Advantage

WuXi Biologics’ TDCC solution delivers speed, scientific rigor, and global flexibility—3 essentials for advancing a TCE program. Over 120 PhD- and MS-level scientists leverage GMP facilities and at least 10 patented technologies to guide each program end-to-end.

Faster Start with Proprietary Technology

Our TDCC reporter cell lines are ready-to-use, allowing immediate program launch and saving months in a fast-moving market. We run reporter-based TDCC assays alongside peripheral blood mononuclear cell (PBMC)–based direct cytotoxicity, delivering 2 complementary data streams for a cross-validated potency profile.

This dual-track approach:

  • Reduces false positives and false negatives
  • Eliminates delays from sourcing, validating, or switching assays

Scientifically Robust, Clinically Relevant Data

Our TDCC assays enhance sensitivity to detect low-affinity TCEs early. The assays also identify Critical Quality Attributes to support process control and product consistency.

Validated to FDA and EMA standards, we produce high-quality, regulatory-ready data for BLA submission.

Flexible, Globally Accessible Solutions

WuXi Biologics’ TDCC methods are transferable and compliant with major regulatory agencies, enabling data use across regions without revalidation. The methods keep results consistent and smooths technology transfer when expanding internationally.

From pre-IND through Phase II, phase-dependent licensing and pricing can significantly cut costs. TDCC can integrate into a WuXi Biologics’ CMC program or run as a standalone service to align scope, delivery, and budget with development strategy.

How Our TDCC Solution Works

From concept to submission, our process gets you started faster and keeps your program moving. Clear IP rights and documented provenance avoid licensing delays and compliance risks.

Choose your assay format Reporter-based and direct cytotoxicity, or both
Launch Immediately Ready-to-use cell banks
Advance with confidence Regulatory-ready data from early development through BLA filing

Technical Capabilities and Compliance

WuXi Biologics’ TDCC reporter cell lines incorporate the TCR–CD3 complex and support CD3–CD28 co-stimulation. This biology, paired with practical advantages, improves assay performance, minimizes equipment needs, and supports global submissions.

Feature

Our Unique Advantage

Your Benefit

Parental Cell Line

Derives from the Jurkat cell line for authenticity and traceability.*

Streamline regulatory review with documented provenance, reducing identity and compliance risks.

Signal Pathway

Expresses the full TCR–CD3 complex and downstream signaling pathways.

Model natural immune synapse formation and reduce assay variability to gain predictive results.

Assay System

Runs on standard plate readers compatible with commercially available luciferase substrate.

Lower capital investment while maintaining sensitivity.

Assay Sensitivity

Widens the detection window under standard seeding conditions.

Detect TCEs with low CD3 affinity to accelerate lead selection.

Functional Properties

Replicates T-cell activation through CD3–CD28 co-stimulation.

Quantitatively optimizes TCE potency via CD3–CD28 co-stimulation.

Quality Standards

Meets EMA and FDA audit standards.

Submit globally compliant data with less risk of regulatory queries or delays.

* ATCC origin

Why Adopt TDCC Early?

Adopting TDCC early in development prevents delays and rework. Functional assays like TDCC reveal a therapy’s MOA, allowing drug developers to base candidate selection on clinically relevant performance. Early TDCC also aligns programs to regulatory expectations, supports process control, and avoids costly method changes late in development.