Notice of Intent to Sole Source : Acquisition of Services for the Manufacture of Clinical Grade Lentiviral Vector Encoding GPC2-CAR
Closed Pre-Solicitation Posted
- Solicitation number
- 75N91024Q00089
- Agency
-
National Cancer Institute
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 325414 Biological Product (except Diagnostic) Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure 250 ml of concentrated lentiviral vectors on a sole source basis from Expression Therapeutics, LLC. The services required include the manufacture of clinical grade lentiviral vector encoding GPC2-CAR, which will be used to engineer T-cells from neuroblastoma patients into CAR-T cells for a Phase I/II clinical trial. The contract requires the vendor to meet cGMP manufacturing requirements, including the use of certified cell lines, GMP-compliant cleanrooms, quality assurance, and stability testing per FDA guidance. The vendor must complete the production and release of the lentiviral vector within 6 months of contract award. Responses to the pre-solicitation notice are due by May 15, 2024, and the government will consider any responses to determine if a competitive procurement is warranted.
This procurement is set aside for small businesses, with a North American Industry Classification System (NAICS) code of 325414 (Biological Product (except Diagnostic) Manufacturing) and a business size standard of 1,250 employees. While this is a sole source procurement from Expression Therapeutics, LLC, any interested party, especially a small business, may submit a capability statement, proposal, or quote for the government to consider. The government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate.
Notice text
The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure 250 ml of concentrated lentiviral vectors, on a sole source basis from:
Expression Therapeutics, LLC
1860 Montreal RD
Tucker, Georgia 30084
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 13.501(a) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325414 (Biological Product (except Diagnostic) Manufacturing) and the business size standard is 1,250 Employees.
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 identified below by no later than 10:00 A.M. EST on Wednesday, May 15, 2024 (05/15/24). 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 “75N91024Q00089” on all correspondence.
Files
| File | Type | Posted |
|---|---|---|
| NOI_75N91024Q00089..pdf | ||
| Att1-SOW_NOI_75N91024Q00089.pdf |
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