Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
ID: PS75N95024R00094_2Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

NAICS

Medicinal and Botanical Manufacturing (325411)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Original Source

https://sam.gov/opp/ddaf430bb5494ac2b358fcd78137880a/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services related to the development of drug substances. The primary objective is to ensure the Division of Preclinical Innovation (DPI) receives drug substances of adequate quality and quantity to support preclinical and Investigational New Drug (IND)-enabling studies, adhering to current Good Manufacturing Practice (cGMP) standards. This procurement is crucial for advancing therapeutics from preclinical stages to market readiness, emphasizing a multidisciplinary approach and compliance with regulatory requirements throughout the drug development pipeline. The Request for Proposals (RFP) is expected to be released on or about October 4, 2024, with contract awards anticipated in the second quarter of FY2025. Interested parties may contact Samson Shifaraw at samson.shifaraw@nih.gov for further information.

    Point(s) of Contact
    Samson Shifaraw
    (301) 480-7153
    samson.shifaraw@nih.gov
    Files
    Title
    Posted
    1-SOW.pdf
    The document outlines the Statement of Work (SOW) for Chemistry, Manufacturing, and Controls (CMC) pertaining to drug substance development by the Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS), NIH. TDB aims to advance therapeutics from preclinical stages to investigational new drug (IND) applications. The scope covers CMC services necessary for drug substance quality and quantity in preclinical studies, involving the development and validation of processes for small molecules, peptides, oligonucleotides, and biopharmaceuticals, adhering to current Good Manufacturing Practice (cGMP). General requirements include contract administration, project management, collaboration, quality management, and compliance with regulatory standards. The document emphasizes the necessity for a multidisciplinary approach, providing trained personnel, maintaining quality assurance, and facilitating independent audits. The tasks encompass process development, analytical method validation, and ensuring the quality and stability of drug substances, with sustainability considerations in supply chain management. The purpose of this SOW is to ensure that the complex process of therapeutic development is carried out effectively, promoting innovation and adhering to regulatory guidelines throughout the drug development pipeline.
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