NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File Maintenance For Antibody Drug Conjugate ADCT-701
ID: 75N91025NOI7142309Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHBethesda, MD, 20892, US

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)

Original Source

https://sam.gov/opp/fb1b653e08e542dbb99c4b514bc693f9/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health, is issuing a notice of intent to sole source a contract for stability testing services and drug master file maintenance for ADCT-701, an antibody drug conjugate targeting neuroendocrine neoplasms. The procurement aims to ensure compliance with FDA regulations through stability studies and maintenance of associated Drug Master Files, with testing to be conducted at -70°C and results reported at specified intervals over a period of up to 60 months. This contract is critical for maintaining the integrity and safety of the drug product, with a firm fixed-price purchase order set to commence on April 17, 2025, and conclude by July 17, 2027. Interested parties may contact Miguel Diaz at miguel.diaz@nih.gov or call 240-276-5439 for further information.

    Point(s) of Contact
    Miguel Diaz
    (240) 276-5439
    miguel.diaz@nih.gov
    Files
    Title
    Posted
    75N91025NOI7142309 - Attachment 1 - SOW.pdf
    The National Cancer Institute (NCI) is seeking stability testing services and drug master file maintenance for ADCT-701, an antibody drug conjugate targeting neuroendocrine neoplasms. This contract aims to ensure compliance with FDA regulations by conducting stability studies—beginning April 17, 2022—for ADCT-701 while maintaining associated Drug Master Files (DMFs). The selected contractor must adhere to cGMP standards and ICH guidelines, performing specific tests on the drug product stored at -70°C, with results reported at predetermined intervals up to 60 months post-manufacture. Failure notifications and timely updates on expiry dates based on stability test outcomes are also required. The firm fixed-price purchase order initiates from April 17, 2025, through July 17, 2027, with all work conducted at the contractor's facilities. The document outlines clear deliverables, such as certified analysis reports and notifications of any stability test failures, and establishes payment terms within 30 days of invoice receipt, emphasizing the government’s role in overseeing contract fulfillment.
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