MANUFACTURE OF PLASMID DNA DRUG SUBSTANCE AND DRUG PRODUCT

NIH RePORTER · NIH · N02 · $1,524,929 · view on reporter.nih.gov ↗

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
MIDWEST RESEARCH INSTITUTE
Principal Investigator
RACHEL GINTHER
Activity code
N02
Funding institute
NIH
Fiscal year
2024
Award amount
$1,524,929
Award type
Project period
2024-09-25 → 2027-09-24