Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances   7

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development.

The scope of this contract is for Chemistry, Manufacturing, and Control (CMC) services for drug substances. The objective of these support services is to ensure DPI receives Drug Substance (DS) of sufficient quality and quantity to support preclinical and IND-enabling studies.

The Contractor shall provide support for a broad range of preclinical services required for the design, development, manufacture, and release of DS, including precursors, preliminary states, Reference Standards (RS) and all required testing. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required, even without an associated cGMP manufacturing task. These include, but are not limited to, process development and process robustness studies, development or engineering lots, and formulation studies. All activities necessary to maintain material in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions may also be required.

While this contract will be primarily in support of the DPI drug development programs, this contract may include support for a range of NCATS activities differing in size, complexity, and duration.

All applicable attachments in connection with this solicitation are available for download.