Immunogenicity system

The contract involves the custom synthesis of 56 peptides, each 15 amino acids in length, for immunogenicity testing purposes. These peptides will be screened against six different HLA-class II alleles to assess their binding capabilities. A stability assay will be performed at a single time point to evaluate the off-rate of each peptide, providing a stability index for analysis. The deliverables include a comprehensive technical report summarizing all peptides tested, with detailed tabulated data and graphical representations for both the binding assays and stability assays. Additionally, the contract requires an analysis of the pan-allele population impact to understand the broader immunological implications. The timeline for delivery is set between 4 to 6 weeks. This contract is issued under a Total Small Business Set-Aside, indicating that only small businesses are eligible to compete. The solicitation number is FDA-10-1077339, with contact points including Allison Mlawsky and Contracting Officer Lisa T O’Neill. The contract falls under the NAICS code 541990, which relates to professional scientific and technical services. The focus of the contract is on supporting immunogenicity assessment through detailed peptide synthesis and subsequent binding and stability analysis.