NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File... Tender

Procurement Summary

Country : USA

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

Deadline : 05 Mar 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 115575106

Document Ref. No. : 75N91025NOI7142309

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

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...
Active Contract Opportunity
Notice ID : 75N91025NOI7142309
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH :
General Information
Contract Opportunity Type: Special Notice (Original)
Original Published Date: Feb 28, 2025 02:13 pm EST
Original Response Date: Mar 05, 2025 12:00 pm EST
Inactive Policy: 15 days after response date
Original Inactive Date: Mar 20, 2025
Initiative:
Classification
Original Set Aside:
Product Service Code: 6505 - DRUGS AND BIOLOGICALS
NAICS Code: 325412 - Pharmaceutical Preparation Manufacturing

Place of Performance: New Providence, NJ 07974 USA

Documents

 Tender Notice