# Software for Determining Proteoform Heterogeneity and Protein Expression Fidelity

> **NIH NIH R44** · GENNEXT TECHNOLOGIES, INC. · 2021 · $480,459

## Abstract

The GenNext Technologies Phase II SBIR proposal entitled “Software for
Determining Proteoform Heterogeneity and Protein Expression Fidelity,” builds upon a
highly successful Phase I program, and will produce a robust, easy-to-use software
package, that uniquely assesses the precision of biotherapeutic protein expression.
 During the last thirty years, the global market for biopharmaceuticals has
prospered, achieving sales of more than $176 billion in 2015. The structure and
functional activity of biopharmaceuticals are dependent on various aspects of their
production and environment. The presence of proteins having improper structures has
been linked to adverse drug reactions (ADR), which range from patient symptomatic
irritation to morbidity and death. The appearance of ADR’s has alerted the
biopharmaceutical industry to the critical role that protein structure plays in the
safety and function of biotherapeutics.
 Biopharmaceutical recombinant protein expression is inherently prone to low-level
errors resulting in sequence variants caused by amino acid misincorporation. The
expression system and culturing conditions can influence protein product quality
attributes, such as translational fidelity and post-translational modifications. These
protein variants impact product quality in a number of ways: altered function; altered
activity; altered ligand/substrate binding; perturbed protein folding leading to protein
aggregation; decreased serum half-life; diminished therapeutic efficacy; and undesired
patient immune response. Concerns for efficacy and patient safety necessitates the
need to characterize these low-level protein variants.
 Upon achievement of our aims, our Phase II proposal will provide biopharmaceutical
researchers a valuable, new software tool that will detect unwanted biotherapeutic
expression variants that can manifest as adverse drug reactions. Our software will
enable researchers to discover the presence of protein expression and post-translational
variants in a facile manner so that they not only understand the nature of these
alterations, but also may improve the expression process to eradicate these artifacts.

## Key facts

- **NIH application ID:** 10257385
- **Project number:** 2R44GM131533-02
- **Recipient organization:** GENNEXT TECHNOLOGIES, INC.
- **Principal Investigator:** Scot Randy Weinberger
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $480,459
- **Award type:** 2
- **Project period:** 2019-01-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10257385

## Citation

> US National Institutes of Health, RePORTER application 10257385, Software for Determining Proteoform Heterogeneity and Protein Expression Fidelity (2R44GM131533-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10257385. Licensed CC0.

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