# Therapeutic Viral (AAV) Vector Platform Biologics Chemistry, Manufacturing and Controls (CMC) Subject Matter Expert Consultant

> **NIH NIH N01** · — · 2021 · $4,875

## Abstract

The specific consultant SME technical areas required are outlined below.
1. Biologics Chemistry, Manufacturing and Controls (CMC) viral vector therapeutics
SMEs
Subject matter experts in manufacturing of viral therapeutics platforms, including but not limited
to modalities such adeno-associated viruses (AAVs), and/or lentiviruses, and other therapeutic
viral vector platforms are required. Biologics CMC consultants will be expected to provide
senior-level chemistry, manufacturing and controls expertise and contribute feedback and
guidance on projects to the NIH and to LDT members through conference calls and by email.
The role of the CMC SME consultant may include, but is not limited to, the following
responsibilities and tasks:
a) Consultants will provide the type of input that will allow the NINDS to design and implement
new programs to address external research needs and objectives
b) In partnership with other consultants, contractors, and the NIH staff, advise, strategically
plan, and manage CMC to facilitate preclinical evaluation and safety testing, IND
submission, and clinical studies
c) Provide strategy and feedback on AAV and/or other viral vector biologics process
development and manufacturing plans proposed by the team
d) Facilitate Team discussions via telephone and email regarding assigned CMC efforts
e) Provide strategic guidance for the continued development and improvement of the
URGenT program
f) Serve as the CMC expert in order to identify potential product manufacturing challenges
and suggest strategies to address these challenges
g) Provide feedback on therapeutic viral vector processes proposed by the team
h) Review and comment on the adequacy of biologic manufacturing including scale-up,
analytical method development, and process development (upstream and downstream
processing) approaches proposed by PIs and CMOs

## Key facts

- **NIH application ID:** 10490589
- **Project number:** 75N95021P00256-0-0-1
- **Recipient organization:** —
- **Principal Investigator:** —
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $4,875
- **Award type:** —
- **Project period:** 2021-05-28 → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10490589

## Citation

> US National Institutes of Health, RePORTER application 10490589, Therapeutic Viral (AAV) Vector Platform Biologics Chemistry, Manufacturing and Controls (CMC) Subject Matter Expert Consultant (75N95021P00256-0-0-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10490589. Licensed CC0.

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