The National Heart, Lung, and Blood Institute is conducting a market survey to determine if there are commercial small businesses capable of producing recombinant B19 pavovirus capsids in a baculovirus system for use in human clinical trials. B19 parvovirus is the etiologic agent of fifth disease, transient aplastic crisis of hemolytic disease, some hydrops fetalis, and some chronic pure red cell aplasia. Using well established technology, parvovirus capsids composed of both the major and minor structural proteins have been produced in conventional insect cell culture after infection with appropriate recombinant baculoviruses. Structural proteins self-assemble into particles, which can be purified from cell lysates by sequential application of centrifugation, ion exchange chromatography, hydrophobic chromatography, size exclusion chromatography, and filtration. Protocols are fully described in Investigational New Drug (IND) BB-IND 8553. Purified B19 parvovirus capsids should be produced in quantities sufficient for planned clinical trials in humans: 1) for a phase I pilot dose-ranging study of normal volunteers, to begin in July 2003, approximately 1 mg; 2) for a phase II/III multicenter vaccine efficacy study, to begin in April 2004, a single lot of 10 mg. Capsids must be produced under good manufacturing practices (GMP), including industry standard quality control and assurance and production and delivery must be according to a pre-arranged schedule. Product must be formulated in the appropriate adjuvant for delivery to participating medical centers. The contractor would be required to maintain the IND with the Food and Drug Administration (FDA). This is not a Request for Proposals (RFP) and one is currently not available. All interested small businesses are requested to submit capability statements, by or before November 25, 2002, which must provide: 1) demonstrated ability to produce and distribute the B19 parvovirus vaccine in accordance with an established IND under GMP and in the quantities required; 2) documented experience with the baculovirus system for production of recombinant proteins; 3) the capability to purify viral capsids in bulk; 4) documented experience producing immunogens for human vaccines; and 5) evidence of working with the FDA and the ability to file and maintain an IND. If your organization does not have the capacity to do this work, you must provide evidence of a partnering agreement with a larger business. The North American Industry Classification System (NAICS) Code applicable to this requirement is 325412, 750 employees. The capability statement must be submitted on or before November 25, 2002, and must reference number NHLBI-PS-2003-019. Seven (7) copies of your capability statement should be delivered to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, 6701 Rockledge Drive, Rockledge Building 2, Suite 6042, Bethesda, Maryland 20892-7902, Attn: Gina Cianflone, Contract Specialist .

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