- Country: USA
- Summary: MMA-101 Stability and Compatibility Studies and CMC
- UST Ref No: 118703581
- Deadline: 16 May 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75N95025R00041
- 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.
- Description:
- 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... - Documents:
Comb_Synop-Solicit-NONCOMPETITIVE-MMA-101-Stabilit.docx
D1-MMA-Stability-Testing-and-regulatory-support-SO.docx
If you are registered member, kindly login to view full details of this tender notice:
CLICK HERE TO LOGINMMA-101 Stability and Compatibility Studies and CMC - 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 MMA-101 Stability and Compatibility Studies and CMC. This tender is published on USARFP under UST Ref No: 118703581 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 2025-05-16.
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.
