Brand Name Justification.docx
DOCX document 13 KB Posted
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- BroadPharm lipids Brand Name Federal contract opportunity
- Solicitation number
- RFQ-NIH-NIAID-2180801
About this file
This document is a brand name justification for the purchase of a proprietary library of 60+ ionizable cationic lipids from Broadpharm, LLC to support the development of mRNA-LNP vaccine capability at the Vaccine Research Center. The lipid library selection is required for continuity in ongoing research and no other lipid manufacturer can meet the criteria of providing an extensive library of over 10 analogues of ALC-0315 and SM-102 lipids that are cationic, ionizable, rapidly degradable in bloodstream, and available in small packaging quantities while also passing quality control assessments. The related federal contract opportunity is a solicitation from the Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases seeking the Broadpharm lipids brand with the product name and number provided.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| FAR 52.212-5 JUN 2023.docx | DOCX document |
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Text version
The Vaccine Production Program (VPP) applies cutting-edge science and engineering approaches to plasmid design, cell expression, purification, formulation, and analytics. The multidisciplinary nature of the work requires expertise in a number of scientific fields, including molecular and cellular biology, biochemistry, biophysics, biomedical and chemical engineering, and traditional pharmaceutics. The broad portfolio of knowledge, coupled with a strong culture of collaboration and innovation, makes the VPP one of the most versatile product development organizations in infectious disease research. Notable achievements include the development of novel quadrivalent and hexavalent mosaic nanoparticle vaccines to fight influenza, as well as breakthroughs in production and stabilization of trimeric protein vaccine candidates for human immunodeficiency virus (HIV) and respiratory syncytial virus (RSV).
This request is for the purchase of a library of 60+ ionizable cationic lipids from the lipid manufacturer Broadpharm, LLC. Acquisition of this equipment is being requested to support the development of for mRNA-LNP technology to enable mRNA-LNP vaccine capability at the VRC. The lipid library will be screed as a key portion of a mRNA-LNP formulation screen.
This lipid library has been selected based on criteria. No other lipid manufacturer has been identified that can provide an extensive library of ionizable cationic lipids (>10 lipids) that meet these criteria. Lipids ALC-0315 and SM-102 are required from BroadPharm for continuity requirements in ongoing research. Do not substitute.
Technical requirements
| • | All lipids are cationic and ionizable |
| • | All lipids structures are analogues of ALC-0315 and/or SM-102 |
| • | All lipid are capable of rapid degradation in the bloodstream (inherent in analogues of ALC-0315 and SM-102) |
| • | All lipids come with quality control assessments of purity by NMR and LCMS |
| • | All lipid are available in small packaging requirements (50 or 100mg), which meet project requirements (many other vendors only provide larger packaging of 1g and above). |
This lipid library is proprietary to Broadpharm and therefore unavailable from any other manufacturer.
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