Acquisitions Management Operations Branch, NIAID, 6700-B Rockledge Drive, Room 1130, Bethesda, MD 20892-7605

R -- PRODUCTION AND SAFETY TESTING OF CLINICAL RETROVIRUS, ADENOVIRUS, ADENOASSOCIATED VIRUS, AND LENTIVIRUS VECTORS FOR GENE THERAPY SOL NIAID-DIR-00-51 POC Donna Baker, Contract Specialist or Karin Eddy, Contracting Officer, 301-496-3878 The Laboratory of Host Defenses, Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for a series of tasks and safety testing relating to production of retrovirus and other vectors such as adenovirus, adenoassociated virus and lentivirus vectors to be used in gene therapy. The goal of the work is to provide vector materials that will result in the ability of NIAID and other NIH staff to conduct clinical gene therapy trials with retrovirus or other vector material that safisfy and conform to all current US Food and Drug Administration (FDA) rules and regulations, including any future changes in FDA rules and regulations regarding these gene therapy related materials. Task may include but will not be limite to: 1) Cell culture expansion, freezing of aliquots of cells and safe frozen storage of producer cells, including the establishment and frozen storage of producer cell Seed Banks (Minibanks), Master Cell Banks and, where appropriate Working Cell Banks; 2)Production, purification and safety testing of clinical grade plasmid DNA to be used for transfection of producer cell lines such as 293T cell line (as one example) for transient expression to the production of clinical gene therapy vector; 3)Production of clinical grade virus vectors supernatants in quantities sufficicient for either pre-clinical research studies or clinical trials. Depending on the type of vector application, the vector production may either involve harvest of vector directly from a producer cell line that is continuously producing such vector or it may involve transient production of vector from a cell line that is first transfected with DNA prepared as in item #2 above; 4) Perform FDA mandated safety testing and characterization of vector DNA and/or producer cell lines or cell banks, including clinical grade retrovirus, adenovirus, adenoassociated virus, or lentivirus vector supernatants or stocks and gene altered patient cells. Safety testing and characterization may include (where applicable) but not be limited to, issues of sterility, presence of replication competent viruses, presence of unwanted adventitial materials, and in case of cell lines, documentation of the identity of the line. The list of required testing will be dictated by published FDA requirements, with modifications determined in consultation between the contractor and the sponsor for each task. It will be the responsibility of the contractor to develop an appropriate characterization and safety testing scheme that will safisfy published FDA requirements for identify and safety of the particular clinical vector product; and 5) Preparation of written records that document all tasks including details of clinical production, testing and characterization that conforms to all FDA regulations regarding such written documentation. OFFERORS MUST MEET THE FOLLOWING MANDATORY QUALIFICATIONS IN ORDER TO BE CONSIDERED FOR CONTRACT AWARD: 1) Offerors must be able to demonstrate the capability to transfer materials to and/or from the Contractor's facility and the NIH Bethesda, MD Campus within one working day and 2) Offerors must provide documentation that the proposed facility has been inspected by the FDA and is in compliance with the established Good Manufacturing Practices and current Good Laboratory Practices. RFP to be issued on or about December 20, 1999. No telephone requests for the RFP will be accepted. See numbered Note 1. Posted 11/01/99 (W-SN396681). (0305)

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