# MANUFACTURE OF PLASMID DNA DRUG SUBSTANCE AND DRUG PRODUCT

> **NIH NIH N02** · MIDWEST RESEARCH INSTITUTE · 2024 · $1,524,929

## Abstract

This task order involves the manufacturing of a unique multi-antigen plasmid DNA vaccine. Elements of the work include the production of the drug substance and the drug product. The production of this vaccine is a multi-step process consisting of generating working cell banks, process development to purify the plasmid, verification of plasmids by next gen sequencing. The drug substance is formulated in a buffer system prior to filling. The initial development runs are done under lab conditions in a research and development environment. However, the follow-up processes to produce product suitable for human use are performed under cGMP.

## Key facts

- **NIH application ID:** 11219072
- **Project number:** 75N91023D00010-0-759102400002-1
- **Recipient organization:** MIDWEST RESEARCH INSTITUTE
- **Principal Investigator:** RACHEL GINTHER
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,524,929
- **Award type:** —
- **Project period:** 2024-09-25 → 2027-09-24

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11219072

## Citation

> US National Institutes of Health, RePORTER application 11219072, MANUFACTURE OF PLASMID DNA DRUG SUBSTANCE AND DRUG PRODUCT (75N91023D00010-0-759102400002-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11219072. Licensed CC0.

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