SPECIAL NOTICE
99 -- Conducting market research to determine whether there is a commercial capability to produce single-donor, lyophilized (freeze-dried) fresh frozen human plasma (LHP) for injection.
- Notice Date
- 2/15/2007
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- USA-SNOTE-070215-006
- Archive Date
- 5/16/2007
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS. IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PU RSUANT TO THIS ANNOUNCEMENT. 1.0 SUBJECT: The US Army Medical Research and Materiel Command (USAMRMC) is conducting market research to determine whether there is a commercial capability to produce single-donor, lyophilized (freeze-dried) fresh frozen human plasma (LHP) for injection . This market research may also assist with the further development and/or refinement of Army and Department of Defense (DoD) requirements. Responses are due to this RFI by 4:00 PM on 19 March 2007. See section 6.0 for further information. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offer will be considered in response to this RFI. Responses to this notice are no t 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 RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 DESCRIPTION: The Directorate of Combat and Doctrine Development (DCDD), the Army Medical Department Center and School (AMEDDCS) is developing requirements documentation to support development of new capabilities for battlefield hemorrhage control that include supply of an FDA-approved, lyophilized (freeze-dried) fresh frozen human plasma (LHP) for use beyond current freezer and resupply capabilities. Minimum US Army requirements for LHP include FDA approval, no greater incidence of severe adverse even ts than currently experienced with fresh frozen plasma (FFP), factor levels within the normal range for FFP, no significant interactions with common operational drugs and vaccines, a portion of the supply must be universal donor, reconstitution in less tha n 10 minutes, unit size approximately 200 ml, and a shelf life of one year when refrigerated (1?C-6?C). 4.0 REQUIREMENTS: The Army wishes to identify any and all commercial entities with the capability to process, produce, and package single-donor, lyophilized human plasma (LHP) for injection, or an equivalent product, according to current good manufacturin g practices (cGMP). A prospective offerorRespondents to this RFI must demonstrate 1) commercially successful prior experience with this type of manufacturing process; 2) current manufacturing operations capable of converting to or subsuming supply to sup port Army needs for up to 1000 units of LHP per month, up to 25% type AB plasma; 3) thorough experience and knowledge of cGMP; and 4) evidence of an awareness of the commercial market conditions for LHP. The Government encourages frankness, creativity, and innovation in responses to this RFI. The purpose of this RFI is to gather information about commercially available products and capabilities that meet the requirements enumerated above. 5.0 CONTACT INFORMATION: The Point of Contact for this RFI is Mr. Aaron Wade, (301) 619-8397, aaron.wade1@us.army.mil.
- Record
- SN01233170-W 20070217/070215221442 (fbodaily.com)
- Source
-
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