# Specificity Screening Drug Development Tool for Biotherapeutic Safety

> **NIH NIH SB1** · INTEGRAL MOLECULAR · 2024 · $917,454

## Abstract

ABSTRACT
Off-target safety problems are the single leading cause of preclinical drug failures. As a result, specificity
profiling has become an FDA requirement for monoclonal antibodies (MAbs) as well as other emerging
biotherapeutic categories such as CAR-T cell therapy. Current methods for profiling the specificity of
biotherapeutics, primarily tissue cross-reactivity studies (TCR) and spotted protein arrays, are poorly predictive
of cross-reactivity against the native human proteome, have low sensitivity, and are difficult to interpret. A
novel approach for specificity profiling is needed to better predict off-target binding of MAbs and de-risk
biotherapeutic discovery programs. Integral Molecular is the industry leader in membrane protein antibody
discovery and characterization. As a result of previous SBIR funding, we developed a new technology for
specificity profiling and deorphaning, the Membrane Proteome Array (MPA). The MPA represents 93% of the
human extracellular proteome expressed in their native conformation in live cells. Recently, the MPA was the
first technology accepted into the FDA’s ISTAND pilot program for drug development tools (DDT).
Development of the MPA would have a large impact on the clinical pipelines of nearly every biopharmaceutical
company and has significant commercial potential.

## Key facts

- **NIH application ID:** 11002039
- **Project number:** 1SB1GM156044-01
- **Recipient organization:** INTEGRAL MOLECULAR
- **Principal Investigator:** Benjamin J Doranz
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $917,454
- **Award type:** 1
- **Project period:** 2024-09-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11002039

## Citation

> US National Institutes of Health, RePORTER application 11002039, Specificity Screening Drug Development Tool for Biotherapeutic Safety (1SB1GM156044-01). Retrieved via AI Analytics 2026-08-17 from https://api.ai-analytics.org/grant/nih/11002039. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*