National Cancer Institute, Research Contracts Branch, PSCS 6120 Executive Blvd, EPS/Room 638, MSC 7228, Bethesda MD 20892-7228

65 -- PRODUCTION OF CYTOTOXIC T-CELL LINES SOL NO2-BC-66202-82 POC Michelle Scala, Contract Specialist or Janet Mattson, Contracting Officer on (301)402-4509. The National Cancer Institute requires the services of a laboratory for the establishment and expansion of T-cell lines using specific tumor associated antigens. Independently and not as an agent of the Government, the Contractor shall furnish services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government. The Contractor must be located as to be able to pick up patient specimens and deliver expanded T-cell lines within 60 minutes ground transport travel time of the National Institutes of Health, Bethesda, Maryland Campus. The offerors must describe in their proposal how this criteria will be met. This contract is for the production and delivery of activated T-cells for administration to cancer patients in adoptive therapy protocols. It is essential that the specimens be picked up and the therapeutic T-cells be transported expeditiously and with as little trauma as possible so that they are viable at the time of administration. Therefore, it is necessary to have a local production facility to avoid potential shipping delays and the use of freeze/thaw storage cycles for cell preservation. Overnight delivery service is not acceptable. The Government shall supply patient and normal volunteer whole blood, tissues (e.g., lymph nodes), peripheral blood mononuclear cells (PBMC), and/or leukopacks to the Contractor for establishment and expansion of T-cell lines using specific tumor associated antigens. The samples shall be identified by code only to ensure patient confidentiality. All cell lines shall be manufactured according to FDA guidelines for human administration. The Contractor shall have relevant Standard Operating Procedures (SOPs) for work under this contract on file and the work shall be performed by laboratory/scientific staff trained in aseptic techniques for cell line production. All supplies, reagents and media shall be handled according to established Contractor SOP procedures. Technical procedures for blood processing and cell line production shall be according to established SOPs. All data generated from this contract work shall be maintained according to FDA guidelines. Good Manufacturing Practice Facility is required. All responsible sources may submit a proposal which shall be considered by the agency. It is anticipated that the proposed contract will be a base year with four one year option periods. Solicitation will be issued o/a March 5, 1996. NO collect calls will be accepted (0045)

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