SPECIAL NOTICE
A -- Screening FDA Approved Compounds for Ebola VLP Entry Inhibition
- Notice Date
- 8/8/2011
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH11T0529
- Archive Date
- 8/7/2012
- Point of Contact
- Lisa Sawyer, 301-619-6661
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(lisa.maria.sawyer@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate a firm-fixed-price purchase order, on a sole source basis utilizing FAR subpart 13.5 - Test Program for Certain Commercial Items with the University of Virginia. Department of Cell Biology under the direction of Dr. Judith White, P.O. Box 400195, Charlottesville, VA 22904-4195, for the services to produce cell lines capable of producing fully human IgG monoclonal antibodies that recognize Ebola Sudan or Marburg virus glycoprotein for the Virology Division at U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) under Other than Full and Open Competition by the authority of the Federal Acquisition Regulation (FAR) Subpart 6.302-1 (c) (i), Only one responsible source and no other supplies or services will satisfy agency requirements. The sole source determination is based the University of Virginia's, Department of Cell Biology laboratory being the only source capable of evaluating viral entry after treatment with FDA approved drugs. Dr. Judy White's laboratory is also the only laboratory with an assay capable of high-throughput testing in vitro that are comparable to the in vitro assays using live-virus used at USAMRIID. The primary objective of the award is a therapeutic countermeasure that can be used to treat or prevent entry of Ebola Zaire. The Contractor for this requirement shall produce cell lines capable of producing fully human IgG monoclonal antibodies that recognize Ebola Sudan or Marburg virus glycoprotein for the Virology Division, USAMRIID. The project shall be completed in three phases, and all three phases shall be completed in the first year of the contract. If USAMRIID requires the same type of services with these or additional filovirus glycoproteins, with two (2) Option Year that may exercised for performance of further work if needed by USAMRIID. I. Phase I: The service provider will generate Ebola virus like particles (VLPs) with the following characteristics: a. Composed of VP40 and GP (either delta mucin or full length) (3 months) b.Provide characteristic information on the VLPs and send them to USAMRIID for evaluation by electron microscopy. (2 months) II. Phase II: The service contractor will provide data from the first screen to identify entry inhibitors. The library of compounds will be provided to the service contractor with the consent of CombinatoRx. a. Test the individual components of the 'hits' to see whether they inhibit entry by filamentous Ebola viral like particles (VLPs) (6 months) b.Compounds will initially be tested in a 3-point dose response curve. In this manner, the compounds will be classified into two major groups: those that inhibit the entry stage of the Ebola virus lifecycle and tho inhibit a post entry stage. (3 months) III. Phase III: The service contractor will provide the USAMRIID the following: a.Further dissect the mechanism of action of all of the entry inhibitors identified in the first screen. Determine whether each specific entry inhibitor inhibits VLP binding, internalization, or fusion using quantitative assays. Data regarding the identification of the mechanism of action of any identified entry inhibitors. (3 months) The North American Industrial Classification System (NAICS) code for this acquisition is 541712, and the size standard is 500 employees. Dr. Judith White at the University of Virginia has extensive experience producing Ebola virus like particles (VLPs) and has developed a well characterized Ebola virus entry assay. Dr. White is capable of making VLPs bearing the full-length Ebola glycoprotein (GP) and (internally) the Ebola virus VP40 (matrix) protein fused to -lactamase. The procedures for making and assaying the VLPs are essentially as described in Tscherne et al. 2010. J. Virol. Methods. 163: 336-343. Basically, if a VLP productively enters a cell (i.e. if its membrane fuses with an endosomal membrane), VP40- -lactamase enters the cytoplasm where it can cleave a preloaded fluorescent - -lactamase substrate. If the substrate is cleaved its color changes from green to blue, which we monitor on a flow cytometer equipped with a violet laser. The assay can be performed in cluster well plates. Currently this is performed in 48 well plates, but will try to scale down to 96 well plates. With 48 well plates, the assay is highly reproducible and has been validated using inhibitors of the vacuolar proton ATPase (bafilomycin) and an inhibitor of endosomal cathepsins (E64d), which are needed to proteolytically prime Ebola GP for fusion. The Z-factor for the current assay is 0.74, which is in an appropriate range for this screening endeavor. No previous procurements have been issued for this requirement. The Government is unaware of any other source that can provide the required screening of FDA Approved Compounds for Ebola VLP entry Inhibition services. Award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. USAMRAA intends to issue a Firm-Fixed-Price purchase order to the University of Virginia for screening of FDA Approved Compounds for Ebola VLP entry Inhibition services unless other sources are identified before response date to this posting. The period of performance shall be on or about 1 September 2011 - 31 August 2012, with two (2) additional 12-month Option Years. This notice of intent is not a request for quotation. No solicitation is available; however, any interested party that believes it can meet the requirements may submit written notification to the Contract Specialist of their interest and bona fide capability to fulfill the requirements. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirements listed. Any responses to this synopsis must be provided in writing and shall include evidence of qualifications, experience, past performance, and proposed cost to provide this type of services. Such information will be reviewed to determine if it is necessary to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement is solely within the discretion of the Government. The due date to submit responses shall be, Monday, 22 August 2011, 3:00 PM EST. Responses will be accepted ONLY by electronic mail to lisa.sawyer@amedd.army.mil.
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