SOURCES SOUGHT
65 -- cGMP VLP Production
- Notice Date
- 8/24/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 5601 Fishers Lane, 3rd Floor MSC 9822, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIAID-1808132
- Archive Date
- 9/15/2016
- Point of Contact
- Pamela E. Nevels, Phone: 240-669-5089
- E-Mail Address
-
pamela.nevels@nih.gov
(pamela.nevels@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is NOT a solicitation for proposals, proposal abstracts, or quotations. This is a Sources Sought notice to determine what size companies are able to perform this requirement. The purpose of this notice is to obtain information regarding: (1) The availability and capability of qualified small business sources; (2) Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) Their size classification relative to the North American Industry Classification System (NAICS) code 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. A. Background.The Laboratory of Infectious Diseases (LID) is dedicated to improving public health by studying viruses that cause human morbidity and mortality. Infections caused by influenza viruses are a significant health burden on the United States, causing up to 49,000 deaths per year (Centers for Disease Control). The current seasonal vaccine is produced each year with three-four influenza A and B virus strains predicted to circulate in the upcoming season. Although the seasonal influenza vaccine is a widely promoted health campaign, it is ill-suited to fight an emerging influenza pandemic or to offer protection against antigenically drifted epidemic strains. First, the efficacy of the vaccine depends on an accurate prediction of what strains will be in circulation because a close antigenic match between vaccine and circulating virus strain is required for protective efficacy. Additionally, the vaccine is usually grown in an egg-based system, which takes at least six months to produce vaccine stocks. If there were an unexpected emergence of a strain (i.e., a pandemic or a significant drift epidemic), production of a specific vaccine would not be ready in time. Accordingly, to protect against a pandemic, an alternative vaccine strategy should be pursued allowing broad protective efficacy and not requiring specific viral antigen matching. An ideal ‘universal' influenza vaccine should be able to provide broad reactivity against drifted seasonal and pre-pandemic/pandemic viruses and be produced quickly to meet public health needs. B. Objective: The goal is this project is to obtain cGMP baculovirus-produced VLPs for subsequent use in human clinical trial experiments after appropriate toxicity and sterility testing is performed. C. Requirements. To produce a minimum of 5 mg of hemagglutinin (HA) protein in a purified cGMP influenza viral-like particle stock, the contractor will: 1) Obtain a pre-Master Cell Bank (pMCB, sometimes referred to as a Master Cell Seed) and will generate a Master Cell Bank (MCB) a) If required by the FDA, a Working Cell Bank (WCB) will be subsequently generated. 2) MCB or WCB will be used in preparation of the Quadrivalent Influenza VLP vaccine for an IND Enabling Toxicology Study and Phase I Clinical Trial. a) If required, pMCB and/or license rights for pMCB will be obtained by vendor from a current influenza vaccine manufacturer, reference storage facility, biopharmaceutical vendor, or other reputable source. 3) Provide pre-Master Virus Bank (pMVB, sometimes referred to as Master Virus Seed) for preparation of each of the four VLP subtypes required for manufacturing of Quadrivalent Influenza VLP vaccine. a) Correspondingly, vendor will prepare four Master Virus Stocks (MVS). b) If required by Client or the FDA, four Working Virus Stocks (WVS) will be subsequently prepared. 4) MVS or WVS will be used for preparation of the Quadrivalent Influenza VLP vaccine for an IND Enabling Toxicology Study and Phase I Clinical Trial. 5) The VLP batches will be manufactured in Vendors cleanroom facility that has been configured to produce Phase I clinical trial material according to the FDA 2008 Guidance for Industry "cGMP for Phase 1 Investigational Drugs". 6) Each subtype VLP will be manufactured at the yield at least 5 mg of HA protein in Sf9 cells in Serum-Free Medium without antibiotics. a) HA quantitation will be performed using single-radial immunodiffusion test (SRID) or other FDA acceptable method. b) The purity, stability and suitability of the VLPs for the IND enabling GLP Toxicology and subsequent Phase I Clinical Trial are the shared responsibility of vendor and LID. To purify VLPs to >90% purity, the contractor will employ one of the following techniques: a) Employ tangential flow filtration and/or affinity chromatography b) Purify VLPs using 2x chromatography c) Run products through a 0.2 micron membrane filter Quality control: a. Assessment of protein content (bicinchoninic acid assay (BCA) and/or SDS page) b. Epitope confirmation (Western blot, electron microscopy) c. Hemagglutination or Neuraminidase Inhibition assay d. All steps in the expression and purification process will be performed in a manner that limits the accumulation of endotoxin. The final endotoxin specification target is 1 EU/mg protein. Endotoxin levels will be evaluated by established commercial methods by the contractor. D. Submission of Capability Statement and Delivery Instructions: In 10 pages or less, respondents should submit a capability statement of their organization which demonstrates their ability to supply the above requirements (see paragraph C. Requirements). Responses must reference the sources sought number and include the following: (1) Name and Address of the Company, DUNS number, (2) Size and type of business, pursuant to the applicable NAICS code 541690 (3) Point of contact with name, title, address, phone, fax and email, (4) Estimate of projected duration of this project, (5) Capability to provide the specifics of this requirement, with appropriate documentation supporting claims of organizational and staff capability (6) Examples of prior completed Government contracts, references, the dollar value of that work, and other related information; (7) List of organizations to whom similar types of services have been previously provided and the dollar value of that work. Please respond by e-mail with a capability statement to Pamela Nevels at pamela.nevels@nih.gov by August 31, 2016 at 4:00 PM EST. E. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. F. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). This announcement is to identify small business firms, however a company of any size may submit a Capability Statement for this announcement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/NIAID-1808132/listing.html)
- Place of Performance
- Address: National Institute of Health, National Institute of Allergy and Infectious Diseases, C. W. Bill Young Center, Building 33, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04239957-W 20160826/160825000121-36a5a2536aea7176869ea2d91429f7a8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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