The Department of Health and Human Services, National Institutes of Health has a requirement for Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances.

The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), conducts translational research on human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, TDB hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, TDB seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development. The TDB model is to operate as a comprehensive small molecule and biologics drug development organization, moving therapeutic candidates through each phase of the preclinical development process until an Investigational New Drug (IND) application is filed with the US Food and Drug Administration (FDA). For certain drug development campaigns, TDB will support studies up to human Phase IIb. TDB conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. TDB’s operational strategy is to combine the capabilities of in-house staff and collaborative partners, who may be the drug originators, with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with a DPI project officer (PO) responsible for overall planning, execution, and reporting.

• The scope of this Statement of Work is Chemistry, Manufacturing, and Control (CMC) services for drug substances. The objective of these support services is to ensure receipt of 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
• 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 ofthe above modified genetically, biologically, or chemically. Novel formats may be needed. Formats could also include Devices or Combination Products
• Technical Area 1: Process Development, Manufacture and Analysis of Small Molecule Drug Substances
• Technical Area 2: Process Development, Manufacture and Analysis of Synthetic Peptides, Oligonucleotides and Related Drug Substances
• Technical Area 3: Process Development, Manufacture and Analysis of Biopharmaceutical Drug Substances