SPECIAL NOTICE
A -- MANUFACTURING PROCESS DEVELOPMENT, VALIDATION, AND PRODUCTION OF ALVAC-HIV (VCP1521) AND DILUENT
- Notice Date
- 5/11/2017
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-17-R-0047
- Archive Date
- 6/10/2017
- Point of Contact
- Jamie Diggs, Phone: 3016192663
- E-Mail Address
-
jamie.l.diggs.civ@mail.mil
(jamie.l.diggs.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisitions Activity (USAMRAA), on behalf of the U.S. Army Medical Material Development Activity (USAMMDA), is issuing a Notice of Intent to Award a Sole Source contract. This is not a request for proposals. This notice does not represent a commitment by the government to pay for cost incurred in preparation and submission of data in response to this announcement. This is a Sources Sought Notice with the intent to award a sole source contract to IDT Biologika GmbH, Am Pharmapark, Dessau-Roßlau, Sachsen-Anhalt, 06861 GERMANY (DUNS 332119734), in accordance with FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements. This requirement is for Manufacturing Process Development, Validation, and Production of ALVAC-HIV (vCP1521) and Diluent. This notice is provided as information to the marketplace, market research and is an invitation for any other qualified companies to express their interest in and demonstrate their capabilities to provide the required work. 1.0 SUBJECT: The US Army Medical Research and Materiel Command (USAMRMC) HIV vaccine program is developing an HIV vaccine that meets the requirements of the US Military. ALVAC-HIV (vCP1521) is designed (in combination with a protein boost) to protect against HIV-1 subtypes B and E. This product was part of a vaccine regimen that demonstrated 31.2% protective efficacy in the RV144 study conducted in Thailand. The US Army plans to build on that partial success by developing new proteins to pair with ALVAC-HIV (vCP1521). Ninety-seven percent (97%) of the HIV-1 infections in US Service members are subtype B, costing US DoD and Veterans Administration millions of dollars per year to treat and care for HIV-positive military and retirees. The Contractor shall provide manufacturing process development, validation and execution to produce the drug substance and drug product, ALVAC-HIV (vCP1521) and diluent (0.4% sodium chloride) to support preparations for clinical trials. 1.1 DISCLAIMER: This sought synopsis/notice to award sole source is issued solely for information and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this notice. All information received in response to this notice shall be marked Proprietary will be handled accordingly. Responses to the notice will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 2.0 DESCRIPTION: 2.1 The work items are to develop and execute manufacturing processes, testing and release, stability testing, and other activities required to produce and release a minimum of 19,000 vials and up to 38,000 vials of ALVAC-HIV (vCP1521) drug product, and an equal number of vials of sterile diluent (0.4% NaCl solution) in compliance with FDA and EMEA regulations for products intended for use in human clinical trials. 3.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to provide the described product, including any necessary lead time. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts. 4.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mrs. Jamie Diggs at jamie.l.diggs.civ@mail.mil no later than the close of business May 26, 2017. Telephonic communication will not be considered as submission or receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-17-R-0047/listing.html)
- Place of Performance
- Address: Am Pharmapark, Dessau-Roßlau, Sachsen-Anhalt, 06861 GERMANY, Germany
- Record
- SN04506420-W 20170513/170512001102-a469115f754b6a784eeda296ff4d2957 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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