Executive Summary

A leading biopharmaceutical company based in India sought to modernize its immunogenicity assessment process by reducing reliance on animal models. By leveraging Quantiphi’s DART platform—featuring human Microphysiological Systems and AI-driven in-silico modeling—the company significantly accelerated its testing timeline while achieving high human relevance. This transformation enabled early detection of immune responses, cost savings, and a scalable solution applicable across both preclinical and clinical development phases.

About the Client

Our client is a leading Indian biopharmaceutical company with over eight biologic products distributed globally.

Industry: Lifesciences
Size: 1,001–5,000 employees
Country: India

Problem Statement

Biosimilar development demands accurate immunogenicity assessments to predict human immune responses. However, the client’s reliance on animal models posed major challenges due to poor human translatability and inconsistent data—leading to increased costs, limited predictive accuracy, and lengthy timelines. With regulatory bodies promoting human-relevant NAMs, an AI-driven, scalable alternative was urgently needed to deliver mechanistically validated immune insights.

Challenges

Poor translational value due to physiological differences between animals and humans
Unreliable prediction of human immune responses
Variability in animal models and inconsistent results
Animal studies were costly, time-consuming, and hindered drug development
Regulatory shift toward New Approach Methodologies (NAMs) demanding human-relevant, scientifically validated systems

The Solution

DART leverages ethically sourced, biobank-derived human stem cell milieu mimicking functional immune system, combined with AI-powered computer vision and deep learning models, to deliver:
- Human-relevant immunogenicity data (ImmunoGEN)
- Automated micrographs analysis
- Rapid, integrated parallel testing involving biochemical assessments
- Quantified phenotypic response detection
The entire system is compact—deployable on a benchtop workstation—enabling seamless integration into existing R&D and quality control workflows.

Customer’s Testimonial

“Assessing the relevance of animal studies in securing regulatory approval for biosimilars is gaining increasing importance. With regulatory agencies advocating for alternative methods to animal testing, innovative solutions—such as Transcell’s human Microphysiological Systems combined with Quantiphi’s AI and ML-driven in-silico modeling—offer promising avenues to create more predictive and effective scientific tools, ultimately protecting human and animal health as well as the environment.”

Impacts

70%

reduction in immunogenicity testing time

100%

relevant to human immune system modeling

Early detection of preliminary immune indicators & mechanistic validation
Scalable deployment with preclinical & clinical phase readiness

Technology Used

DART (Digital Animal Replacement Technology)

DART (Digital Animal Replacement Technology)

Human Microphysiological Systems

AI/ML-driven image analysis

Deep learning segmentation for immune response prediction

High-resolution microscopy with automated pipelines

Results

Generated human-relevant immunogenicity data using a validated human hematopoietic system, improving accuracy and predictivity over traditional animal-based approaches.
Accelerated bioassay timelines through rapid, parallel in-vitro testing and early detection of immune responses.
Reduced costs significantly by eliminating the need for animal studies, saving both time and resources—especially during clinical development stages.
Enabled automated detection and reporting of early immune signals, including antigenicity and anti-drug antibodies, using AI-powered analysis.
Scaled in-house testing operations, providing the client with full control over immunogenicity data across the organization.