ENDOTOXIN, STERILITY AND GENERAL SAFETY TESTING SERVICES

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Bioreliance, Rockville, MD 20850 Requirements list: 1) Isolator Sterility Testing Using a Direct Inoculation Method on Pfs230D1-CRM197: 0.32 mg/mL lot MV-10010 sample CAT # 360195GMP.BSV QTY: 1 2) LAL Test for Endotoxin (Quantitative, Kinetic, Chromogenic, Assay) on Pfs230D1-CRM197: 0.32 mg/mL lot MV-10010 sample CAT # 510120GMP.BSV QTY: 1 3) Isolator Sterility Testing Using a Direct Inoculation Method on Pfs230D1-EPA: 0.32 mg/mL lot MV-10009 sample CAT # 360195GMP.BSV QTY: 1 4) LAL Test for Endotoxin (Quantitative, Kinetic, Chromogenic, Assay) on Pfs230D1-EPA: 0.32 mg/mL lot MV-10009 sample CAT # 510120GMP.BSV QTY: 1 5) Isolator Sterility Testing Using a Direct Inoculation Method (Upto 250ml TA or 40 vials) - 40 x 0.4 mL vials CAT # 510120GMP.BSV QTY: 1 6) General Safety Test, GMP - 35 x 0.4 ml vials CAT # 509888.BSV QTY: 1 7) LAL Test for Endotoxin (Quantitative, Kinetic, Chromogenic, Assay) - 4 x 0.4ml vials CAT # 360195GMP.BSV QTY: 1 8) Isolator Sterility Testing by Direct Inoculation (Up to 100 ml TA or 20 vials) - 1 x 20 ml TA CAT # 510120GMP.BSV QTY: 1 9) SHIPPING AND HANDLING COST - 9000 ROCKVILLE PIKE, BETHESDA, MD 20892 Sole Source Justification: These tests are required for clinical trial approval from the Food and Drug Administration (FDA). The requested tests are for evaluation and characterization of the vaccine product before use in humans; specifically, endotoxin, sterility, and general safety testing of the finished vaccine product; and endotoxin and sterility testing on the intermediate production step. The testing must be done on fresh sample, never being frozen. These tests will show the LMIV and the FDA if the product is safe for use in NIAID's clinical trials. Bioreliance is the approved vendor to perform the testing and provide the test results required by the FDA. These services are needed for quality control testing of the Pfs230D1-CRM197 Drug Product as part of initial characterization studies and in support of investigational new drug (IND) applications to the FDA. Bioreliance is the approved vendor to perform the testing and provide the quarterly test results required by the FDA for this project, Pfs230D1-CRM197. BioReliance has provided the data in the format we need for reporting to the FDA for obtaining clearance to start a human clinical trial to test our malaria vaccine candidates. BioReliance uses standard protocols that are established with the FDA and require no additional explanation to the FDA. The specific tests in this request are Endotoxin (LAL Test for Endotoxin, Quantitative, Kinetic, Chromogenic, Assay), sterility (Isolator Sterility Testing Using a Direct Inoculation Method), general safety (General Safety Test, 21 CFR 610.11 GMP) LMIV has approved the protocols and methods used by BioReliance for this continuous project PFS230D1 CRN197 and choosing another vendor at this point in our mission related work would be detrimental for our malaria vaccine human clinical trials. These tests will prove the LMIV and the FDA if our product is safe for use in our clinical trials. Changing vendors in this ongoing project is not acceptable. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-23-2185126 to Diana Rohlman at diana.rohlman@nih.gov by 4:00 pm eastern standard time, August 29, 2023. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.