SYNTHESIS OF NON-GMP SMALL MOLECULES Base Year Increment 1

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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.