SOLICITATION NOTICE
A -- The delivery of a current Good Manufacturing Practices (cGMP) multivalent filovirus vaccine using the Virus Like Particle (VLP) platform.
- Notice Date
- 1/2/2013
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY13R0012
- Response Due
- 1/31/2013
- Archive Date
- 3/3/2013
- Point of Contact
- Nathan C. Jordan, 508-233-6034
- E-Mail Address
-
ACC-APG - Natick (SPS)
(nathan.c.jordan@us.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- The U.S. Army Contracting Command Aberdeen Proving Ground Natick Division (ACC-APG-NCD) is providing notice that a Request for Proposal (RFP), W911QY-13-R-0012, for the delivery of a current Good Manufacturing Practices (cGMP) multivalent filovirus vaccine using the Virus Like Particle (VLP) platform will be issued on or about 31 January 2013 with an anticipated contract award on or about 15 Jul 2013. This is a total small business set-aside competition and all responsible or qualified sources are eligible to compete. In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the SAM database. SAM registration can be accomplished at the following website: https://www.sam.gov. The North American Industry Classification Platform (NAICS) codes for this procurement are 541711, Research and Development in Biotechnology. The Government does not intend to use FAR Part 12 for this acquisition. The Government intends to serve as the regulatory sponsor and platform integrator for this effort. The objective of this procurement is to deliver, after limited advance development, a current Good Manufacturing Practices (cGMP) multivalent filovirus vaccine using the VLP platform that will be suitable/acceptable for use in humans by the Government to support non-clinical and Phase 1 studies under an Investigational New Drug (IND) application. The manufacturer shall develop, abide by and document cGMP and processes consistent with the International Conference on Harmonization (ICH) Q7and ICH Q5A- Q5E, FDA regulation 21 CFR Part 211 21 CFR Part 600. In addition to delivering a cGMP final vaccine product to support clinical and nonclinical efforts, the Contractor shall conduct formulation studies to support the development of a filovirus vaccine as well as analytical assay development, including in-process and release assays of cGMP bulk(s) and final product, and International Conference on Harmonization (ICH)-compliant stability testing. Formulation studies will include exploration of adjuvants. The intended product is a subunit, vector-free, multivalent vaccine consisting of multiple VLPs each expressing two antigens, glycoprotein (GP) and a matrix protein (VP40) of the filovirus strains. The VLPs are spontaneously produced in cells when the two genes encoding GP and VP40 are expressed ectopically. These VLPs have a morphology that is strikingly similar to the authentic filovirus with the GP expressed on the surface, traversing the envelope and a layer of matrix protein (VP40) underneath the envelope. Proposals will be evaluated based on Factors, Subfactors, and Elements representing the quote mark Best Value quote mark to the Government. Delivery schedules of the vaccine product shall be proposed by the offerors and will be used as one of the criteria associated with a Best Value evaluation. The proposed schedule calling for delivery of the Multivalent Filovirus Vaccine, as described above, is anticipated within 3 to 4 years after contract award, but all proposed delivery schedules will be evaluated. Interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released on or about 31 January 2013 at the FedBizOpps website hyperlink https://www.fbo.gov/. Search on solicitation number W911QY-13-R-0012. No paper copies of the RFP will be provided and no mailing list will be maintained. Questions or correspondence should be directed by e-mail to usarmy.detrick.cbms.mbx.filorfp@mail.mil and please reference the RFP number W911QY-13-R-0012. Contracting Office Address: The U.S. Army Contracting Command Aberdeen Proving Grounds (ACC-APG) Natick Division, 1564 Freedman Drive, Fort Detrick, MD 21702 Point of Contact(s): Nathan Jordan, Nathan.c.jordan.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/0e40119d9d3fc5c64d22186b1bc87405)
- Place of Performance
- Address: ACC-APG - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN02957346-W 20130104/130102233603-0e40119d9d3fc5c64d22186b1bc87405 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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