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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 30, 2013 FBO #4236
DOCUMENT

87 -- Specific Pathogen Free (SPF) embryonated chicken eggs - Vet. Services Memo

Notice Date

6/28/2013
 

Notice Type

Vet. Services Memo
 

NAICS

112310 — Chicken Egg Production
 

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

2013-56439
 

Archive Date

7/9/2013
 

Point of Contact

Maria S Shamburger,
 

E-Mail Address

HEG9@cdc.gov
(HEG9@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

Guidance on preparing veterinary biological products that use embryonated chicken eggs. Specific Pathogen Free (SPF) embryonated chicken eggs Background: This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the ability to furnish research grade Specific Pathogen-Free (SPF) eggs (also called spafas) to the National Center for Immunization and Respiratory Diseases (NCIRD) Coordinating Center for Infectious Diseases (CCID), Influenza Division (ID), Centers for Disease Control and Prevention. Background: The World Health Organization (WHO) recommends that influenza vaccine seed candidates are produced in Specific Pathogen Free (SPF) embryonated chicken eggs. The vaccine seed candidates are to have the antigenic properties of the recommended strain, and improved growth properties for more efficient vaccine production. SPF eggs are produced under strictly isolated conditions to guarantee the absence of all disease agents and antibodies against specified agents which are laid down in the European Pharmacopoeia and by the USDA. SPF eggs are generally used for all live vaccines and also for killed vaccines. The Influenza Division (ID) currently participates in two projects to produce vaccine seed candidates. One project involves the production of high growth vaccine seed candidates using high growth reassortants and the other produces seed candidates for live attenuated influenza vaccines (LAIV). In the laboratory in Influenza Division, the high growth reassortant influenza viruses have been prepared by infecting an embryonated chicken's egg with high growth reassortants. The goal has been to generate reassortants that contain internal genes from A/PR/8/34 virus plus the hemagglutinin (HA) and neuraminidase (NA) gene segments of the newly-recommended wild type strain. For growing the vaccine seed virus, the eggs from closed, specific-pathogen-free, healthy flocks are recommended by World Health Organization. As new vaccines candidates are required yearly for seasonal and non-seasonal influenza vaccines, on-going production of vaccine seeds is required using Good Laboratory Practices (GLP) and Good Manufacturing Processes (GMP) using SPF eggs. Live attenuated influenza vaccines (LAIV), delivered intranasally, have been under development for more than 30 years. Being well tolerated and causing only mild upper respiratory infection symptoms in humans, LAIV induce immune response similar to natural infection with influenza. LAIV is as effective as, and in some cases more effective than, inactivated influenza in preventing influenza infection. In some studies, LAIV appeared to be more effective in preventing influenza infection than trivalent inactivated influenza vaccine when the vaccine virus strain does not closely match that of the circulating wild-type virus. There are two ways to prepare LAIVs: 1) using classical reassortment between wild type (wt) viruses recommended by WHO for vaccine production and viruses-donors of attenuation (att); or 2) by means of reverse genetics (RG) using plasmids encoding genes of wt and att viruses. All licensed LAIVs are currently produced in embryonated specific pathogen-free (SPF) eggs. Allantoic fluid from infected SPF eggs is harvested and clarified by centrifugation to remove cellular debris. Other than sterile filtration and dilution to the appropriate dose, no additional downstream processing is required. Thus, the number of doses produced per egg is significantly higher than that of inactivated vaccine. In addition, several days in vaccine production can be saved by avoiding the splitting and inactivation steps required for inactivated vaccines. Development and production of LAIV in multiple countries would help achieve the above listed objective of the WHO. Until recently, live attenuated influenza vaccines (LAIV) have been licensed in only two countries, the Russian Federation and the United States. India recently started production and licensed LAIV and Thailand is in late stage development of LAIV using the Russian cold-adapted donors of attenuation, A/Leningrad/134/14/57 and B/USSR/60/69. The wider international use of LAIV based on donors of attenuation developed in Russian Federation prompted WHO to request that CDC establish a backup facility to the existing facility in Russia to prepare and incorporate quality assessment of LAIV reassortants for international use. LAIV vaccine reassortants can be prepared by using either classical reassortment or RG. NCIRD intends to prepare and supply Reassortants to WHO and/or WHO Sub-licensees so designated by WHO. The Influenza Division will develop a reliable procedure to generate LAIV seed strains through Classical reassortment between WHO recommended vaccine viruses and master donor strains developed in the Russian Federation, A/Leningrad/134/17/57 (for influenza type A vaccines) and B/USSR/60/69 (for influenza type B vaccines). This approach uses viruses grown in chicken's eggs that have been recommended by WHO for inclusion as vaccine viruses. Describe the work: NAICS Code 112310 Chicken Egg Production. The objective of this requirement is to furnish a minimum of 360 highest quality grade SPF eggs and a maximum of 540 highest quality grade SPF eggs in any one week delivery period. The contract will include the following requirements: • The Contractor shall guarantee the eggs are sanitized after collection and stored in environmentally controlled holding rooms prior to shipping. • The Contractor shall guarantee that a minimum of 95 percent of the SPF chicken eggs are viable at delivery. The production of SPF chicken eggs shall be performed in filtered air positive pressure (FAPP) poultry housing, sufficient biosecurity measures and quality layer flocks. • Each shipment shall contain a quality control sheet documenting biological assays performed as a quality control measure indicating all pathogens tested. In addition the eggs are to be negative for chicken anemia virus. All eggs are to be Specific pathogen free fertile eggs based on USDA memo 800.65 and European Pharmacopoeia requirements. • For the live vaccine project, the Contractor shall furnish to the ID an immunization history and shall advise if any additional live virus vaccines are administered to the flock during the term of the contract • Abide by all relevant federal regulations • Provide all packaging materials for shipment • Eggs shall be placed in crates immediately after collection and shall be stored in a room with controlled temperature (50-60 degrees F) until shipped. • Shipping crates should contain quantity shipped, antigen testing results and vaccine history of the flock. List Contractor Requirements: Contractors must respond to all the following points, by indicating your experience and ability to provide: (1) Eggs for vaccine seed production that are tested for over 30 specific pathogens according to USDA requirements and chicken anemia virus negative according to European pharmaceutical requirements. (2) A facility that follows PhEur 5.2.2 and USDA memorandum 800.65 for flock rearing and testing methods. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Maria Shamburger, Contracting Specialist, heg9@cdc.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above. Teaming Arrangements: All teaming arrangements shall include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted not later than (7/8/2013) Capability statements will not be returned and will not be accepted after the due date. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates the CDC to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the Central Contractor Registration (CCR). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the CCR located at http://www.ccr.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit. All capability statements can be submitted via e-mail, facsimile, or regular mail to the point of contact listed below. Responses shall be limited to 10 pages. Responses must be submitted no later than (7/8/2013) Documentation should be sent to: Maria Shamburger, Contract Specialist 2920 Brandywine Road Atlanta, Ga 30341 Heg9@cdc.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2013-56439/listing.html)
 

Document(s)

Vet. Services Memo
 

File Name: EUROPEAN PHARMACOPOEIA 5.2.2 (http://lib.njutcm.edu.cn/yaodian/ep/EP501E/05_general_texts/5.2.__general_texts_on_vaccines/5.2.2.%20Chicken%20flocks%20free%20from%20specified%20pathogens%20for%20the%20production%20and%20quality%20control%20of%20vaccines/5.2._2.pdf)

Link: http://lib.njutcm.edu.cn/yaodian/ep/EP501E/05_general_texts/5.2.__general_texts_on_vaccines/5.2.2.%20Chicken%20flocks%20free%20from%20specified%20pathogens%20for%20the%20production%20and%20quality%20control%20of%20vaccines/5.2._2.pdf

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: At Contractor's facility/To be determined, United States
 

Record

SN03103068-W 20130630/130628235041-e5bed42ff2b3312aa737faba5ff1b49e (fbodaily.com)
 

Source

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

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