Tender Details

Country: USA
Summary: NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File Maintenance For Antibody Drug Conjugate ADCT-701
UST Ref No: 115575106
Deadline: 05 Mar 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: 75N91025NOI7142309
Purchaser's Detail:
Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details.
Login to see details
Description:
Description
The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Developmental Therapeutics Branch plans to procure, on a sole source basis, stability testing services from:

ADC Therapeutics America, Inc.
430 Mountain Avenue, Suite #404
New Providence, NJ 07974

The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325412, Pharmaceutical Preparation Manufacturing, and the business size standard is 1,300 Employees.

ADCT-701 is a humanized antibody which effectively suppresses tumor growth and improves survival in multiple cancer models. The National Cancer Institute (NCI) currently holds the Investigational New Drug (IND) application for this proprietary drug product, with the corresponding protocol having received approval from the Institutional Review Board (IRB). To stay in compliance with federal regulations, samples of the drug production batch used in the clinical trial must be stored under stable conditions and regularly tested for their stability for the duration of the trial.

NCI obtained its ADCT-701 production batch from the manufacturer and patent holder for this drug, ADC Therapeutics. No other known vendor on the market can produce ADCT-701. Furthermore, ADC Therapeutics holds the production batch samples that are to be tested for stability in long-term storage under continuous stable conditions. The vendor cannot provide their product to another company because transportation of the samples could impact their stability profiles. Thus, ADC Therapeutics is the only known vendor who can continue to perfor...
Documents:

If you are registered member, kindly login to view full details of this tender notice:

NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File Maintenance For Antibody Drug Conjugate ADCT-701 - USA Tender

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH, a Government sector organization in USA, has announced a new tender for NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File Maintenance For Antibody Drug Conjugate ADCT-701. This tender is published on USARFP under UST Ref No: 115575106 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-03-05.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.