REQUEST FOR INFORMATION RFI Number: W911QY-10-S-0002 INTEREST IN ABILITY TO ISOLATE BUTYRYLCHOLINESTERASE FROM PLASMA COHN FRACTION IV-4 This is a Request for Information (RFI) for planning purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified business sources, (2) including small businesses; HUB Zone small businesses; service-disabled 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 for the proposed acquisition. The North American Industry Classification System (NAICS) Code(s) is/are 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for performing large scale purification of human butyrylcholinesterase (hBuChE) from human plasma fraction IV-4 paste (FrIV4). BACKGROUND: The mission of the Chemical Biological Medical Systems - Medical ldentification and Treatment Systems Joint Product Management Office (CBMS-MITS JPMO) is to rapidly provide the Warfighter with safe, robust, affordable medical countermeasures (MCMs) against a broad spectrum of chemical, biological, radiological and nuclear (CBRN) threats. Current CBMS-MITS JPMO products include Food and Drug Administration (FDA) approved drugs and diagnostic devices. REQUIREMENT: The Department of Defense (DoD), through the CBMS-MITS JPMO, is seeking information from Contract Manufacturing Organizations with the ability to perform large scale purification of human butyrylcholinesterase (hBuChE) from human plasma fraction IV-4 paste (FrIV4). The purified hBuChE will be used as a bioscavenger to protect Warfighters from incapacitation and/or death resulting from exposure to organophosphorus compounds. The hBuChE must be highly pure (greater than 98%) and manufactured with a process amenable to scale up to commercial manufacturing capacity (800-1000g/yr). In addition, the process must ultimately be executed in accordance with Current Good Manufacturing Practices (cGMP) regulations and guidelines, result in formulations that are suitable for use in humans and which support FDA licensure. PURPOSE AND OBJECTIVES: CBMS-MITS is seeking information in order to increase its knowledge regarding the capability of CMOs to isolate highly purified hBuChE, and is requesting the following information: " Ability to execute the representative and successfully employed purification process provided in Appendix A (see also U.S. patent number: US 7,754,461 B2). In addition to replicating this process, the CBMS-MITS JPMO will consider alternate purification strategies as long as they do not negatively impact product quality, cost or schedule. " Estimated cost and schedule required for executing purification process " Anticipated risks associated with executing purification process " An example of a small-scale process with estimated yields and a strategy to increase the scale of this process to commercial scale. " An estimate of the number of runs at commercial scale that can be executed in a calendar year. " An estimate of the amount of protein isolated per run (in mg hBuChE per kg FrIV4 paste). " An approximate cost for a small scale run (suitable for Phase 1clinical trial in human subjects) and for a commercial scale run. " A description of the ability to manufacture in a manner compliant with cGMP. " A description of acceptance criteria for starting material (FrIV4 paste) " Past performance in production of plasma products for use in humans. SUBMISSION INSTRUCTIONS: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within ten (10) days after RFI release. All written responses must be received by Friday, November 5, 2010. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to EMAIL ADDRESS:
contact@example.gov ; (3) be minimum 11 font on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the address below. Material that is advertisement only in nature is not desired. DISCLAIMER AND IMPORTANT NOTES: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. 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 organizations 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 the 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 which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO CBMS Natick, RDE COM Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address:
contact@example.gov See Attachment
