MMA-101 Stability and Compatibility Studies and CMC
SAM.GOV Due: May 16, 2025 at 08:00 PM UTC
In-Active Combined Synopsis/Solicitation Source Url

Summary

The opportunity titled "MMA-101 Stability and Compatibility Studies and CMC" is a combined synopsis/solicitation issued by the National Institutes of Health (NIH) for conducting stability testing, Chemistry Manufacturing and Controls (CMC) regulatory support, and compatibility studies for the investigational product MMA-101, aimed at treating isolated methyl malonic acidemia. The selected contractor will be responsible for extending stability testing of cGMP lots for up to 48 months, providing regulatory documentation support, and performing compatibility studies with clinical devices. This non-competitive solicitation is particularly suited for businesses with expertise in pharmaceutical stability testing, regulatory compliance, and compatibility studies, especially those familiar with gene therapy products and cGMP standards.
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 request

Entities
HAHSDO
Department of Health and Human Services
NIOH
National Institutes of Health
NAICS
541380
Set Aside
None
Point of Contact
Full Name Email Phone Type
Kaitlyn Landi [email protected] 3018271804 primary
KJ Shaikh [email protected] 3014351777 secondary
Attachments
  • D6+Invoicing+Instructions.pdf
  • Comb_Synop-Solicit-NONCOMPETITIVE+MMA-101+Stability+and+Compatibility+Studies+and+CMC.docx
  • D3+FAR+52.204-26+%28Oct+2020%29.pdf
  • D5+FAR+52-222-52+%28May+2022%29.pdf
  • D2+FAR+52.204-24+%28Nov+2021%29.pdf
  • D1+MMA+Stability+Testing+and+regulatory+support+SOW+18MAR2025.docx