65 -- Preparation of MasterCell Bank

The Food and Drug Administration intends to award a non-competitive Purchase Order on a sole source basis to Charles River Laboratories, Inc. FDA will purchase the following and there are no potential substitutes. 1. The Laboratory of Enteric and Sexually Transmitted Diseases has developed three separate vaccine candidate Salmonella strains that have been patented by FDA. Patent law requires that each of these strains be produced in a characterized cell bank for the quick availability to patent licensees. 2. There are currently two commercial entities who have applied for the above mentioned patent with the National Institutes of Health (NIH) Technology Transfer Office, these entities are reliant on the production of these Salmonella strains by the end of Sept. 2007. In order to meet the above legal requirements, FDA must to develop characterized cell banks within the prescribed timeframe and to its specifications. If FDA were to miss the deadline it would violate agreements established with the commercial entities, and possibly patent law, as well as delay development of much needed vaccines. Requirement: Cell Bank Preparation (MCB) Preparation of 100 vials including the following tests: Phenotypic & Microbiological Analysis Purity, Identification and Viability Testing of Microbial Suspensions 3. Produce under cGMP manufacturing conditions three 100 vial cell banks, each comprising a separate Salmonella enterica serovar Typhi Ty21a strain expressing different foreign antigens. Strain A is S. Typhi Ty21a(pXK50) which expresses the Shigella sonnei form I lipopolysaccharide(LPS) genes. Strain B is S. Typhi Ty21a(pSd1) which expresses the Shigella dysenteriae serotype 1 LPS genes. Strain C is S. Typhi Ty21a(PA) which expresses the Bacillus anthracis protective antigen(PA) in a secreted form. 4. Each strain, when provided by FDA, will be grown in specified nutrient media, washed, concentrated and lyophilized to generate 100 vials, each containing between 5 x 109 and 1010 viable CFUs/vial. Vials will be stored at 4C prior to characterizing a sample of vials for purity, viability, and strain identification. After characterization, each Master cell bank will be transferred to FDA. 5. Production of the three cell banks must be completed by Sept. 30, 2007. Charles River Laboratories is the only known company who can guarantee quality of product and completion of the cell bank by the specified date, under the criteria referenced above. Any manufacturing delay or development of inadequate or contaminated samples will have wide reaching ramification, including but not limited to breaking agreements with commercial entities and risk the health of potential vaccine recipients. NO REQUEST FOR QUOTE (RFQ) IS AVAILABLE. Notwithstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to: Darren.Jansen@fda.hhs.gov . No phone calls will be accepted. An award will be made in fifteen (15) calendar days from the date of this notice. This sole source procurement will be awarded using FAR Part 12 Simplified Acquisition Procedures and Commercial Items in accordance with FAR Subpart 13.