H_JUSTIFICATION_FOR_OTHER_THAN_FULL_AND_OPEN_COMPETITION.docx

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION:

Testing of the E. coli rEPA master and working cell banks

I. Background The Laboratory of Malaria Immunology and Vaccinology Research (LMIV), conducts basic research in malaria immunology and pathogenesis, develops and produces prototype malaria vaccines, and conducts clinical trials of promising vaccine candidates. The lab's goal is to develop malaria vaccines that will reduce severe disease and death among African children and pregnant women and to eliminate malaria from low-transmission areas of the world. Testing of the E. coli rEPA master and working cell banks as required by the Federal Food and Drug Administration (FDA) as part of our IND filing to the FDA.

The rEPA master and working cell banks are the starting material for the manufacture of the conjugation partner used to make our conjugate vaccine(s). The testing part of this PO is several tests (Retention of Selectable Markers, Retention of the Recombinant Construct, DNA Sequencing, Analysis of Gene Copy Number and Restriction Endonuclease Analysis of Plasmid DNA) required to be in compliance with current FDA standards. The results from these tests will be included in our future INDs to be submitted to FDA as part of our applications to test our vaccines in healthy human volunteers. The results will show that our cell banks are safe and suitable for cGMP manufacturing. Without this testing LMIV will be unable to proceed with the clinical evaluation of our recombinant II. Justification for Other than Full and Open Competition ☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Sole Source The Laboratory is unable to change the vendor, because Charles River Laboratories is a listed vendor in the vaccine approval process. If we were to change vendors, the NIAID would lose the FDA approval of our Conjugate vaccines for human use. If this was to occur, it would cost the government Signiant funding, and stop all current human trails.