# DCP - Biopharmaceutical Development Program (BDP) Support

> **NIH NIH N01** · LEIDOS BIOMEDICAL RESEARCH, INC. · 2024 · $965,760

## Abstract

The Contractor shall operate a Biopharmaceutical Development Program (BDP), currently a contractor-operated facility in contractor-leased space established by the NCI to develop and produce clinical-grade biopharmaceuticals, including but not limited to: monoclonal antibodies, recombinant proteins, immunoconjugates, peptide and DNA plasmid vaccines, viruses, cell therapies, and other biologicals. The BDP also provides biopharmaceutical development expertise in the areas of cell culture, purification, characterization, analysis, vialing, and Food and Drug Administration (FDA) regulatory compliance. Although the mission of the BDP in support of the NCI and other entities, as requested through NCI, is to manufacture small to medium scale quantities of clinical-grade biopharmaceuticals under current Good Manufacturing Practices (cGMPs) for use in Phase I and II clinical trials, in exceptional circumstances NCI may also require the use of this facility to conduct similar work for synthetic pharmaceuticals (e.g., sterile filling for i.v. solutions). The BDP shall comply with U.S. FDA regulations and guidelines as is appropriate to meet compliance level requirements for each product manufactured. Products intended for use in Exploratory IND clinical trials shall be manufactured and tested in accordance with the FDA’s guideline, “Guidance for Industry, Investigators, and Reviewers – Exploratory IND Studies.” Products intended for Phase I clinical trials are manufactured in accordance with the guideline, “Guidance for Industry – cGMP for Phase I Investigational Drugs.” Products intended for Phase II and non-pivotal Phase III clinical trials shall be manufactured following those aspects of 21 CFR 211 that apply to investigational use products.

## Key facts

- **NIH application ID:** 11219801
- **Project number:** 75N91019D00024-0-759102400011-24
- **Recipient organization:** LEIDOS BIOMEDICAL RESEARCH, INC.
- **Principal Investigator:** lynn briscoe
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $965,760
- **Award type:** —
- **Project period:** 2024-09-28 → 2025-08-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11219801

## Citation

> US National Institutes of Health, RePORTER application 11219801, DCP - Biopharmaceutical Development Program (BDP) Support (75N91019D00024-0-759102400011-24). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11219801. Licensed CC0.

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