SOURCES SOUGHT
A -- Cohn fraction IV-4 paste, a derivative or precursor thereof, or an alternate processing intermediate derived from pooled human plasma, as raw material for subsequent CGMP processing into a therapeutic product intended for FDA licensure
- Notice Date
- 4/21/2014
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- 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
- W911QY-14-S-0004
- Response Due
- 5/6/2014
- Archive Date
- 6/20/2014
- Point of Contact
- Leo Fratis, (301)619-7421
- E-Mail Address
-
ACC-APG - Natick (SPS)
(leo.fratis@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- SYNOPSIS This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. PROJECT REQUIREMENTS The Department of Defense (DoD) Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (MCS-CDP) Joint Product Management Office (JPMO) has a requirement to develop and deliver FDA licensed butyrylcholinesterase (BChE). DynPort Vaccine Company LLC (DVC), a CSC company, is the Prime Contractor for this effort. On behalf of DVC, the MCS-CDP JPMO is seeking interest by commercial entities with the capability to supply Cohn fraction IV-4 paste, a derivative or precursor thereof, or an alternate processing intermediate derived from pooled human plasma, as raw material for subsequent CGMP processing into a therapeutic product intended for FDA licensure. A continual supply is required to support process development, process optimization, process validation, and CGMP manufacturing. Respondents must provide evidence that they are capable of supplying material lots meeting specifications below and at quantities of approximately 1000 kilograms a month, for up to 3 years. Acceptance Criteria for Raw Material 1.An FDA Licensed plasma collection facility. 2.An FDA-licensed plasma fractionation facility and process. 3.The quality of the material must comply with the requirements as codified in 21 CFR parts 600-640, 21 CFR parts 210-211 and Recommendations and Guidelines published by the FDA DHHS. 4.The human plasma pools used for further processing must be tested serologically for absence of adventitious agents. The plasma pool shall be free of: hepatitis B (HBsAg); human immune virus Types 1 and 2 (HIV-1 and HIV-2); hepatitis A virus (HAV); hepatitis B virus (HBV); hepatitis C virus (HCV); and B19 virus (B19V). The results of the serological tests must show no adventitious agents detected, with the exception of B19 which must be less than 1.5 x 104 infectious units (IU)/mL. Respondents to this notice must provide, as part of their response, a capability statement that includes, clear and convincing documentation of their capability of providing the requirement as specified in this notice. The information submitted must be must be in an outline format that addresses each of the elements of the project requirement. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if provided. The North American Industry Classification Systems (NAICS) code for this notice is 325414, Biological Product (except Diagnostic) Manufacturing (with a size standard of 500 employees). The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., large business, small business, small disadvantaged business, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. Responses must be in either Microsoft Word, Portable Document Format, or MS Power Point formats. Preferred media is electronic. Material that is advertisement only in nature is not desired. All responses to this notice must be submitted electronically to leo.j.fratis.civ@mail.mil. The response must be received on or before May 6,2014. The Government and its contractor, DVC, will retain comments and information received in response to this notice. Proprietary information should be identified as Company Proprietary. Do not use Government Security Classification markings. Any information provided to the U.S. Government in response to this sources sought notice is for planning purposes only and will not be used as a selection consideration factor in any U.S. Government contract competition. Should the U.S. Government elect to pursue the subject requirement, an official Request for Proposal will be released at a later date in accordance with FAR Part 5. This Sources Sought Notice allows qualified sources for this requirement to self-identify. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for any information solicited. No solicitation document exists or is guaranteed to be issued as a result of this notice. Army Contracting Command - Aberdeen Proving Ground/Natick Division, Attn: Mr. Leo Fratis, 110 Thomas Johnson Drive, Suite 240, Frederick, Maryland 21702
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/b9e43090acaf28af825e186d32ba79e1)
- 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
- SN03343595-W 20140423/140421234046-b9e43090acaf28af825e186d32ba79e1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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