Developing a Cruelty-Free Potency Testing Strategy for Antisera Products
Executive Summary
A leading Indian antisera product manufacturer producing life-saving antitoxins and antivenoms sought to eliminate the ethical and operational challenges of animal-based potency testing. The company needed a scientifically validated, cruelty-free alternative capable of providing accurate potency measurements across all production stages without disrupting existing workflows.
Using Quantiphi’s DART platform, the manufacturer adopted an AI-driven, human-relevant bioassay system leveraging microphysiological blood and neuronal models. The solution enabled non-animal potency measurement, enhanced reproducibility, and delivered a fully automated, regulatory-aligned workflow, establishing a new industry standard for cruelty-free testing.
About the Client
The client produces antisera and antivenom products against snake and scorpion bites, as well as antitoxins for tetanus, diphtheria, and gangrene, with a global footprint in over 70 countries.
- Industry: Life Sciences (Small molecule drug discovery)
- Size: ~1500 employees
- Country: India
Problem Statement
The client, a global antisera-based biologics manufacturer producing treatments against snake and scorpion bites, as well as tetanus, diphtheria, and gangrene antitoxins, relied heavily on animal-based potency testing to determine the median effective dose (ED₅₀) for each production batch. This process required significant animal use, incurred high operational costs, and faced increasing regulatory and ethical scrutiny. The company needed a cruelty-free, scientifically validated alternative that could deliver accurate potency data across all production stages—without depending on animal models or disrupting its large-scale manufacturing operations spanning 70+ countries.
Challenges
- High animal sacrifice per batch for ED₅₀ measurement.
- Ethical and public scrutiny over continued animal-based testing practices.
- Inconsistent results due to biological variability in animal subjects.
- Operational inefficiency and increased cost per production cycle.
- Growing regulatory and stakeholder pressure to transition to cruelty-free methods.
The Solution
DART introduced a non-animal potency testing strategy that utilizes human microphysiological (blood and neuronal) models combined with AI/ML-driven analytics to measure in-vitro neutralization effects equivalent to traditional ED₅₀ assays.
The system provided:
- Human-relevant potency quantification through advanced microphysiological modeling.
- AI/ML-powered bioassay analysis for precise, reproducible results.
- Digital integration with existing production workflows, enabling seamless deployment.
- Ethical, cruelty-free validation aligned with global testing standards.
By embedding this automated, non-animal testing solution into its production line, the client achieved reliable potency assessments that maintained scientific accuracy while eliminating animal use.
Customer’s Testimonial
“For decades, the industry and the concerned authorities have been looking at cruelty-free testing solutions. So, when DART was presented as a thoroughly researched cruelty-free workstation solution supporting potency measurements that requires no additional infrastructure, we added it to our practice for seamless integration in our production workflow. I am very pleased with the value proposition.”
Director, Antisera Manufacturing Company
Impacts
- Achieved cruelty-free potency assessments across all production stages.
- Significantly reduced reliance on animal testing, improving ethical compliance.
- Integrated seamlessly into existing production workflows without additional infrastructure.
- Enhanced accuracy and reproducibility of potency readouts.
- Set a new operational standard for sustainable biologics manufacturing.
Technologies Used
Quantiphi’s DART Platform
Human Microphysiological Models (Blood and Neuronal)
AI/ML Analytical Pipelines
Automated Potency Quantification Systems
Results
- Measured the effective dose (ED₅₀) accurately with no extrapolation to clinical context required.
- Reduced dependence on mice-based testing through adoption of a validated, in-vitro potency strategy.
- Transferred DART’s digital bioassay SOPs into in-house workflows for continuous use and scalability.
- Established a robust, ethical, and reproducible potency testing framework across global operations.