IMMUNOGENICITY & INNATE IMMUNE RISK ASSESSMENT SERVICES

Human-Relevant, IND-Supporting Assays by BioECMCode

BioECMCode also provides non-clinical immunogenicity risk assessment using human primary cell–based platforms designed to support IND-enabling programs. Our assays combine functional T cell activation readouts with innate immune profiling, enabling early identification of immunogenic liabilities across biologics, peptides, and complex formulations.

Overview

Our platforms have been successfully applied in regulatory-facing programs, including studies supporting IND submissions. We focus on human-relevant, functional assays that help teams characterize immune activation risk early and generate actionable non-clinical data for development strategy.

Core Capability: DC:T Cell Immunogenicity Assay (ELISpot)

We offer a validated human DC:T (DC:CD4⁺ T cell) co-culture assay to assess antigen-driven immune activation.

Human PBMC-derived CD14⁺ monocytes → dendritic cells (DCs)

DCs are loaded with test article and matured

Co-culture with autologous CD4⁺ T cells

Functional readout via IFN-γ ELISpot

What It Measures

Antigen-specific T cell activation
Immunogenic potential of:
- Drug product (DP)
- Impurities
- Formulations / excipients

Why It Matters

Functional, human-relevant readout
Supports risk ranking prior to clinical studies
Aligns with regulatory expectations for non-clinical immunogenicity assessment

Proven Performance

Low background activation for low-risk molecules
Strong response in positive controls confirms assay sensitivity

Expanded Readouts: Multiplex Cytokine Profiling

IL-6, MCP-1, IL-8, IFN-γ, and additional panels
Captures breadth of immune activation
Enables signature-based risk assessment

Expanded Readouts: Donor Diversity

Multi-donor panels representing HLA diversity
Improves translational relevance and de-risking

Innate Immune Activation & Safety Testing: TLR Activation Assays

Evaluate pattern recognition receptor (PRR) activation
Identify unintended innate immune stimulation
Useful for:
- Biologics
- mRNA/LNP systems
- Impurities and aggregates

Innate Immune Activation & Safety Testing: Monocyte Activation Test (MAT)

Human cell–based alternative to endotoxin/pyrogen testing
Detects pro-inflammatory cytokine release
Supports safety and release strategy development

Applications

Preclinical immunogenicity risk assessment
Impurity profiling and comparability studies
Formulation optimization
IND-enabling support packages
Mechanistic studies for immune activation pathways

Why Us?

Human primary cell–based systems (PBMC-derived)
Functional, biologically relevant readouts
Experience supporting regulatory-facing studies
Flexible assay design tailored to your molecule

Get Started

We work with pharma, biotech, and CRO partners to design fit-for-purpose immunogenicity strategies.

Study design consultation
Timeline & donor availability
Custom panel development