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Manufacture and characterization of Pichia master and Working Cell bank

General Information

Document Type:PRESOL
Posted Date:Oct 19, 2018
Category: Miscellaneous
Set Aside:N/A

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 5601 Fishers Lane, 3rd Floor MSC 9822, Bethesda, Maryland, 20892, United States

Description

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 manufacture and characterization for our 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. PfCSP is LMIVs pre-erythrocytic component needed for the manufacture of our VIMT (vaccine to interrupt malaria transmission) vaccine a critical component of all of LMIVs malaria vaccine development strategy. To be in compliance with current FDA standards the starting material for GMP manufacture of recombinant protein should be two tiered master and working cell banks prepared following cGMP regulations Without cGMP cell banks we will be unable to manufacture and the testing of our VIMT in clinical trials. 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 before they can be accepted into any cGMP facility (including our CMO). The testing for identity, purity and suitability for our cell banks in inclusive of having the cell banks manufactured. 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-1933470) to Skye Duffner at skye.duffner@nih.gov by 2:00 pm eastern standard time, October 29, 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.

Original Point of Contact

POC Skye Duffner, Phone: 4068026092, Laura L Grey, Phone: 406-375-9812

Place of Performance

Address:
5640 Fishers Lane, Rockville, Maryland, 20852, United States
20852,
Link: FBO.gov Permalink
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