Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
Closed Solicitation Posted
This opportunity was awarded. See its 4 award notices in the notice history.
- Solicitation number
- 75N95025R00005
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- Place of performance
- Rockville, Maryland 20850, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is seeking Chemistry, Manufacturing, and Controls (CMC) services for drug product development. The solicitation aims to secure comprehensive support for designing, developing, manufacturing, and releasing drug products across various formats including small molecules, peptides, biologics, gene therapy vectors, and nanoparticles. Contractors must provide capabilities for formulation development, cGMP manufacturing, analytical method development, stability testing, and quality control activities. Technical evaluation will focus on five key factors: Technical Plan/Approach (40 points), Scientific and Technical Personnel (20 points), Facilities and Equipment (15 points), Quality Management (15 points), and Organizational Experience (10 points). Potential offerors must submit proposal questions by December 23, 2024, with final proposals due by February 3, 2025, at 3:00 PM local time.
The solicitation does not have a specific small business set-aside, though it includes subcontracting goals of 32% for small businesses, 5% for small disadvantaged businesses, 5% for women-owned small businesses, 3% for HUBZone, and 3% for veteran-owned small businesses. The contract will be an Indefinite Delivery/Indefinite Quantity (IDIQ) agreement with a 6-year ordering period from September 30, 2025, through July 31, 2031, with a minimum guaranteed value of $1,000 and a maximum potential value of $49,885,703. Typical production quantities will range from 500-5,000 units for non-GMP products and 1,000-10,000 units for cGMP clinical trial materials. The primary place of performance will be in Potomac, Maryland, with potential work spanning multiple technical areas including small molecule drug products, synthetic peptides and oligonucleotides, and biopharmaceutical and gene therapy drug products.
Notice text
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.
Files
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Notice history
| Notice | Type | Posted |
|---|---|---|
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Award Notice | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Award Notice | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Award Notice | |
| This notice | Solicitation |
4 of 5 notices listed here. See the rest on GovTribe.
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