SOLICITATION NOTICE
68 -- Parvovirus B19 Vaccines
- Notice Date
- 6/6/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PS-2003-019
- Response Due
- 7/7/2003
- Archive Date
- 7/22/2003
- Point of Contact
- Gina Cianflone, Contract Specialist, Phone (301) 435-0366, Fax (301) 480-3345, - Debra Hawkins, Chief, Procurement Section, Phone (301) 435-0366, Fax (301) 480-3345,
- E-Mail Address
-
gc35c@nih.gov, dh41g@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A 100% SMALL BUSINESS SET ASIDE. The North American Industry Classification System (NAICS) code is 325414. The small business standard is the Number of Employees is not to exceed 500. This is a synopsis for commercial items, prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. Proposals are being requested and a written solicitation will be issued. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) has a requirement for the production of recombinant B19 parvovirus 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 (9 month phase) dose-ranging study of normal volunteers , approximately 1 mg; 2) for a phase II/III (15 month phase) multicenter vaccine efficacy study, 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). The contractor period of performance will be a two (2) distinct phase project for an estimated 24 months. The award of a fixed price, indefinite delivery (requirements) type contract is anticipated. The solicitation document will be released on or about June 20, 2003 with a due date on or about July 7, 2003. Interested parties should submit a written request via mail or facsimile transmission to (301) 480-3345 for a copy of the solicitation number NHLBI-PS-2003-019 to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, Building RK2, Room 6146, 6701 Rockledge Dr., Bethesda, Maryland 20892-7902. Attention: Gina M. Cianflone, Contract Specialist. All responsible sources may submit a proposal, which if timely received, shall be considered by the Government.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00341617-W 20030608/030606213243 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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