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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH has floated a tender for MMA-101 Stability and Compatibility Studies and CMC. The project location is USA and the tender is closing on 16 May 2025. The tender notice number is 75N95025R00041, while the TOT Ref Number is 118703581. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : MMA-101 Stability and Compatibility Studies and CMC
Deadline : 16 May 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 118703581
Document Ref. No. : 75N95025R00041
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Login to see detailsTender Details
Description
(i) This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.
(ii) The solicitation number is 75N95025R00041 and the solicitation is issued as a request for proposal.
This acquisition is for a commercial product or commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Products and Commercial Services; and FAR Part 12—Acquisition of Commercial Products and Commercial Services and is expected to exceed the simplified acquisition threshold.
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME).
The National Center for Advancing Translational Sciences (NCATS) is collaborating with the National Human Genome Institute (NHGRI) to advance an adeno-associated virus gene therapy candidate as possible treatment for isolated methyl malonic acidemia (MMA), and intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Viralgen, with the address at: Parque Tecnológico de Guipuzcoa, Paseo Mikeletegui, 83, 2a Planta, 20009 San Sebastián, SPAIN (1) to perform the stability testing of the cGMP lots for additional time points up to 48 months for MMA-101 using the program specific and validated analytical methods; b) provide Chemistry Manufacturing and Controls (CMC) regulatory support for the investigational product MMA-101; and c) to per-form a compatibility study for MMA-101 and the clinical devices that will be used in the clinical tri...
Active Contract Opportunity
Notice ID : 75N95025R00041
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NIDA
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
Original Published Date: May 05, 2025 09:29 am EDT
Original Date Offers Due: May 16, 2025 04:00 pm EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: May 31, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code: Q301 - REFERENCE LABORATORY TESTING
NAICS Code: 541380 - Testing Laboratories and Services
Place of Performance:
Documents
Comb_Synop-Solicit-NONCOMPETITIVE-MMA-101-Stabilit.docx
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