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FBO DAILY ISSUE OF MARCH 14, 2012 FBO #3763
SOLICITATION NOTICE

B -- Acquisition of Sheep Antisera Against H1N1 pdm Virus for Includsion in Annual WHO Kit

Notice Date

3/12/2012
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

000HCVGD-2012-43549
 

Archive Date

3/20/2012
 

Point of Contact

Linda M Young, Phone: (770) 488-2655
 

E-Mail Address

lml3@cdc.gov
(lml3@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Medgene, 1006 32nd Avenue, Suite 104, Brookings, SD 57006, for acquisition of sheep antisera against H1N1 pdm virus for inclusion in the annual World Health Organization (WHO) kit manufactured by Medgene, Inc. Background: CDC manufactures the annual WHO reference reagent kit using inactivated influenza viral preparations and sheep sera against influenza viral proteins. During 2009, when the H1N1 pdm virus emerged, developing antisera against H1N1 pdm became very challenging due to additional cleavage sites in the HA protein resulting in an internally cleaved HA protein resulting in non-immunogenic HA protein particles. South Dakota State University (SDU) maintains a flock of sheep. During the H1N1 pandemic, one subject matter expert in the Influenza Division established a contract with SDU to use recombinant proteins, rather than native proteins, and an alternative approach to a traditional vaccine strategy to generate highly tittered H1N1 pdm antisera that supported the influenza division and FDA with H1N1-specific sera for 2 years. CDC has now exhausted all of their stock of H1N1 pdm sera and desperately needs more sera for in house surveillance to support seasonal annual influenza strain selection and for inclusion in the 2012-13 annual WHO kit. Need: Minimum of 600 mls of sheep antisera against A/H1N1 pdm strain of influenza and a final report. Requirement: 1. Timed sera (20 mls) obtained from bleeds based on the vaccine schedule previously employed to produce antisera to H1N1pm; 2. Final sera (600 mls) upon the determination by CDC SMEs meeting the titers required for use in the WHO kit; 3. Final report. Assumptions and Expectations: 1. All confirmatory testing will be performed at CDC; 2. Immunization schedule has been projected to last longer than expected and may need to be reduced if the resulting titers meet the expectations of the government. CDC will notify SDU with further instructions per the contract based on CDC testing results. Prior to progression to the next step in the progress CDC must be consulted to ensure that the optional titer with the lowest cross reactivity is acquired. 3. If titers are not reached, CDC will accept the final product per the protocol. 4. SDU will acquire the adenoviral construct specific to the H1N1 pdm virus included in the solicitation. 5. SDU will acquire the necessary approvals for the indicated work per the requirements of the Institutional Care and Use Committee (IACUC). 6. Vendor will be responsible for shipping costs. 7. CDC will provide sequence for the andeoviral vector and the protein immunogen. Technical requirements and Delivery Schedule: Four (4) sheep will be acquired and maintained during the duration of the experiment. Delivery schedule is as follows: 1. Twenty (20) mls of sheep sera from each animal will be required prior to immunization; 2. Twenty (20) mls of sera from each animal are due two (2) weeks post initial prime dose of immunogen; 3. Twenty (20) mls of sera from each animal are due two (2) weeks post first and second boost doses of immunogen; 4. Twenty (20) mls of sheep sera from each animal are due two (2) weeks post adenoviral vector immunization or third boost of immunogen; 5. Final bleed (minimum of 600 mls of sera) will be due one week after CDC has performed final testing. CDC testing will take a maximum of 2 weeks after receiving the sera post adenoviral vector immunization. 6. Final report documenting the entire process with results of the study to include animal weights, animal ages, clinical signs, and problems encountered, etc. should be included in the report. 7. Shipments of sera should occur immediately post bleed at 4°C. Options: 1. Two (2) of the four (4) sheep will be maintained for an additional 9 months after the initial period of performance. 2. An additional 600 mls of sera may be required. 3. The other two (2) sheep may need to be maintained for an additional year after the award of the contract. 4. Additional immunizations with Adenoviral vector or immunogen. Period of Performance: Base contract: 3 months. Options for maintenance of sheep: additional 9 months. Personnel: Project coordinator which includes data analysis and blood sample collection, and provision of IACUC approval and animal care procedures, injections and blood collections, including final serum collection under general anesthesia; laboratory manager to assist in all bleeds and vaccinations, purification of serum for shipment to CDC, communications assistance, and coordination of project activities, as well as final serum preparation and assistance in procedure using general anesthesia; plus additional technical support for animal capture and care. Sheep to be procured at current lamb prices, four outbred sheep approximately 1-2 years of age. Finished product must function properly in WHO kit by detecting H1N1 pdm field isolates. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 13.106-1(b)(1). Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/000HCVGD-2012-43549/listing.html)
 

Place of Performance

Address: 1600 Clifton Road, Atlanta, Georgia, 30333, United States

Zip Code: 30333
 

Record

SN02694543-W 20120314/120312235004-0a970b97ab7d21cb78dce591aeeefa4e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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