What is the primary advantage of Whole Slide Imaging (WSI) for bispecific antibody toxicology?

The primary advantage is the generation of quantitative, unbiased data. WSI combined with computational algorithms allows for the objective measurement of cellular changes, immune infiltration, and biomarker expression across an entire tissue section. This approach can detect subtle or multifocal toxicologic findings that may be missed by traditional, semi-quantitative microscopic evaluation, providing a more robust safety profile.

How does WSI integrate with computational pathology algorithms?

WSI creates a high-resolution digital replica of the glass slide, which serves as the input for computational analysis. These algorithms are trained to perform tasks such as automated cell counting, spatial analysis of different cell populations, and quantification of protein expression. This integration transforms subjective observations into objective, reproducible endpoints suitable for regulatory submission.

Why are NHP models preferred for bispecific antibody safety assessment?

Non-human primate (NHP) models are preferred due to their high degree of immunological and genetic homology to humans. For bispecific antibodies, which function by engaging the immune system, an NHP model provides the most translationally relevant data for predicting potential liabilities like cytokine release syndrome (CRS) and on-target, off-tumor toxicities.

What GxP standards apply to digital histology data?

Digital histology data generated for regulatory studies must adhere to GxP principles ensuring data integrity. This includes maintaining secure, unalterable raw data files, complete audit trails that track all user actions and algorithm parameters, and validated, secure systems for long-term data archiving. These controls ensure the data package is reliable and defensible for IND submissions.

High-content whole slide imaging (WSI) provides the quantitative, objective toxicologic pathology data required to de-risk bispecific antibody development in non-human primate studies. By replacing subjective assessment with algorithm-driven analysis, this methodology identifies subtle, multifocal, or rare toxicities with high precision. This level of detail is fundamental to building a robust IND-enabling data package, supporting an accelerated 18-24 month development timeline.

Animal Welfare and Regulatory Compliance

Our approach aligns with the 3Rs principles of Replacement, Reduction, and Refinement by extracting more quantitative information from fewer tissue samples.

All studies are conducted in our AAALAC- and USDA-accredited, >100,000 sq ft facility, ensuring the highest standards of care and compliance. This rigorous operational framework has supported our clients in achieving a 100% IND success rate since 2019, a track record we continue under the Franklin Biolabs brand launched in 2024. Through strategic partnerships with leading computational pathology platforms, we deliver data packages optimized for regulatory review.