Production of Monoclonal Antibody

The National Institute of Allergy and Infectious Diseases (NIAID) intend to procure from GeneImmune Biotechnology the following: Twenty (20) each of Monoclonal Antibody and two (2) each of DNA Prep, 10 mg. The vendor will be required to provide the following: 1. 5C9/IgG2a(VRC2742/VRC9746) mAb production by HEK293 suspension cells 2. Purification by Protein G 3. Purity > 95% by SDS-PAGE 4. Low endotoxin level: <50EU/mg 5. Functional detection to VRC01 by ELISA 6. Deliver final antibodies in PBS 7. Summary of results 8. 10mg DNA prep of VRC2742 and VRC9746 The Government will provide targeted mAb in expression vector. The incumbent vendor is able to deliver high-quality product with minimal lead time. They are able to guarantee and document purity levels and have experience producing reagents that are compatible with ongoing NIH vaccine trial-related protocols. The use of products from another vendor would result in an increase in variance amongst trials. This will be a firm fixed price contract in accordance with the statutory authority for this sole source requirement 41 U.S.C. 3304 (c) (1) as implemented by FAR 6.302-1 only one source available, no substitutions possible, and this item contains proprietary information. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-78, dated November 25, 2014. The associated North American Industry Classification System (NAICS) Code is 325414, which has a size standard of 500 employees. All responsible sources who feel they can meet these requirements shall submit an offer that will be considered by the Agency. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Offers must be submitted no later than 5:00 P.M. Eastern Time Monday, December 29, 2014 through the U.S. Postal Service or preferred carrier to NIH/NIAID/AMOB, 5601 Fishers Lane, Room 3B24, MSC 9822, Bethesda, MD, 20892 (Fedex 20852). Email and fax submissions are acceptable. Point of contact concerning this requirement is James Kish, who can be reached by phone at 240-669-5110, f 240-6270-3150, or e-mailed to kishj@niaid.nih.gov.