Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products

The Therapeutic Development Branch (TDB) within 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 Products. The

objective of these support services is to ensure receipt of formulated Drug Product (DP) of sufficient quality and quantity to support preclinical, IND-enabling and clinical studies.

The Contractor shall provide support for a broad range of preclinical services required for the design, development,

manufacture, and release of DP, and release of DP as Clinical Trial Material (CTM), including precursors, preliminary

states, Reference Standards (RS) and all required testing. Ancillary products (e.g., placebos, diluents, adjuvants,

master cell banks, testing standards, reference materials) and other materials manufactured or purchased to

support clinical trials or CMC activities may also be required. All activities preliminary to manufacturing in

accordance with current Good Manufacturing Practice (cGMP) may be required (e.g., development or engineering

lots, formulation studies), even without an associated cGMP manufacturing task. All activities required 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.

Product formats may include small molecules, short oligomeric compounds, biological (large) molecules,

quaternary molecular assemblies (homogenous or heterogenous), vectors for gene therapy, nanoparticles, and any

of the above modified genetically, biologically, or chemically. Novel formats identified after this draft might also be

needed. Formats could also include Devices or Combination Products. The breadth of this Statement of Work (SOW) includes capabilities to support a range of activities differing in size,

complexity, and duration.

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