NOTICE OF INTENT TO SOLE SOURCE: Stability Testing Services And Drug Master File Maintenance For Antibody Drug Conjugate ADCT-701
Closed Special Notice Posted
- Solicitation number
- 75N91025NOI7142309
- Agency
-
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
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- New Providence, New Jersey 07974, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services (HHS), specifically the National Institutes of Health (NIH) National Cancer Institute (NCI), has issued a Special Notice of Intent to Sole Source stability testing services for the antibody drug conjugate ADCT-701. The notice announces the intent to procure these services directly from ADC Therapeutics America, Inc. located in New Providence, NJ. This acquisition will be processed under FAR Part 12 for commercial items and is exempt from standard competitive procurement requirements. The unique nature of the procurement stems from ADC Therapeutics being the sole manufacturer and holder of the drug production batch samples for ADCT-701, a humanized antibody designed to suppress tumor growth. The drug is currently under an Investigational New Drug (IND) application held by the NCI, with an approved protocol from the Institutional Review Board.
Contractors interested in this opportunity must submit a written capability statement, proposal, or quote via email to Contracting Officer Miguel Diaz by 12:00 P.M. EST on March 5, 2025. While the notice is not a competitive solicitation, the government will consider responses from interested parties, particularly small businesses, to determine if alternative vendors can meet the requirement. To be eligible, contractors must be registered and have valid certification through SAM.GOV. The primary objective is to conduct stability testing of the ADCT-701 drug batch, including physical state analysis, protein concentration, purity testing, and cytotoxicity assays over a specified period from April 2025 to July 2027. Additionally, the contractor must maintain four FDA Drug Master Files related to the drug's components. Respondents should provide sufficient details to allow NCI to assess their capability to perform the required services, with the understanding that the government retains full discretion in determining whether to proceed with a competitive procurement.
Notice text
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 perform ongoing stability assessments of this drug.
This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government’s needs, it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other information furnished must be in writing and must contain sufficient details to allow NCI to determine if the party can perform the requirement. Responses to this notice shall be submitted via email to Contracting Officer, Miguel Diaz, at miguel.diaz@nih.gov no later than 12:00 P.M. EST on Wednesday, March 05, 2025 (03/05/25). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered for the purpose of determining whether to conduct a competitive procurement.The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. To receive an award, Contractors must be registered and have valid certification through SAM.GOV. Please reference the notice number 75N91025NOI7142309 on all correspondence.
***Please reference attached Statement of Work for more details pertaining to the nature of the work to be performed.***
Files
| File | Type | Posted |
|---|---|---|
| 75N91025NOI7142309 - Attachment 1 - SOW.pdf |
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