# SYNTHESIS OF NON-GMP SMALL MOLECULES Base Year Increment 1

> **NIH NIH N02** · ALCHEM LABORATORIES CORPORATION · 2023 · $305,000

## Abstract

The Pharmaceutical Resources Branch (NCI/DCTD/DTP/PRB) requires a contractor that will provide services, personnel, equipment, and facilities as required to perform process development and synthesis of bulk materials under cGMP conditions. The quantity of a given material to be synthesized may range from multiple grams to multiple kilograms. These materials are required to be manufactured via well-defined and validated chemical processes, to be of high purity, and to be well-characterized. They are intended for use in formulation development, pharmacology and toxicology studies, and clinical trials. Major aspects of the contract work scope will include: (1) cGMP process development to transform laboratory-scale procedures to a robust and reproducible large-scale process; (2) synthesis of bulk chemicals/drugs on multi-gram to multikilogram scale as needed; (3) analysis for ensuring the purity, identity, and quality of the prepared compounds including QA/QC for the cGMP batches; and (4) additional studies such as solubility/stability as needed.

## Key facts

- **NIH application ID:** 10788101
- **Project number:** 261201700007I-P00001-759102200001-1
- **Recipient organization:** ALCHEM LABORATORIES CORPORATION
- **Principal Investigator:** JAMES TALTON
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $305,000
- **Award type:** —
- **Project period:** 2022-06-05 → 2023-06-04

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10788101

## Citation

> US National Institutes of Health, RePORTER application 10788101, SYNTHESIS OF NON-GMP SMALL MOLECULES Base Year Increment 1 (261201700007I-P00001-759102200001-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10788101. Licensed CC0.

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