Testing and Analysis for Pichia master and working cell banks

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 Charles River Laboratory, Wilmington, MA to procure the service of Pichia cell master and working cell banking testing and analysis.

The testing and analysis of these cells will be used in support of ongoing research at the Laboratory of Malaria Immunology and Vaccinology (LMIV) to research, pursue, produce and clinical trial malaria vaccines. Place of Performance is Rockville, MD 20852.

Testing of the Pichia Pvs230D1 cGMP master and working cell banks as required by the FDA as part of a our IND filing to the FDA. Pvs230D1 is LMIV's lead P. vivax transmission blocking vaccine candidate. The previously prepared Pvs230D1 master and working cell banks are the starting material for the manufacture of the recombination protein that will be used to make the vaccine. To be in compliance with current FDA standards our two tiered cGMP manufactured master and working cell banks have to be tested for identity, purity and suitability. This is for several remaining tests that are required to be in compliance with current FDA standards. The results from these test will included in an IND to be submitted to FDA as part of our application to test our vaccine 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 Pvs230D1 transmission blocking vaccine candidate.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 6.302-1 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-1920949) to Skye Duffner at skye.duffner@nih.gov by 2:00 pm eastern standard time, August 23, 2018. 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.

.