SOURCES SOUGHT
66 -- Circular Dichroism Spectrometer
- Notice Date
- 6/20/2011
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1088717
- Archive Date
- 7/13/2011
- Point of Contact
- Roy E. Mutch, Phone: 404-253-1258
- E-Mail Address
-
roy.mutch@fda.hhs.gov
(roy.mutch@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantage businesses and HUBZone firms, Veteran and Service-Disabled Veteran-Owned small businesses, and Women-Owned small businesses. This notice is for planning purposes only, and does not constitute as invitation for Bids, a Request for Proposals, Solicitations, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the partof the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission the being requested or reimburse expenses incurred to interested parties for responses to this Sources Sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any small business that can provide the following: 1. Circular Dichroism Spectrometer - 1 ea Statement of Work In this project, we propose to intensively characterize using methods beyond those typically employed at lot release. For this purpose, we will use a model protein, protamine sulfate, from various sources. It is the only drug approved by FDA to reverse the anticoagulant effects of heparins. Protamine, isolated from sperm nuclei of fish, is a complex mixture of several similar peptides which are rich in arginine and positively charged. It is administered by IV routes. It has been suggested that the biological activities of protamines are primarily based upon the ability of these positively charged peptides present in the protamine to bind to other negatively charged biomolecules (e.g., polysaccharides). Structural attributes of protamine, such as molecular weight distribution, charge density, secondary structure, can have a significant impact on it binding to polysaccharides, and thus affect the safety and efficacy of the final drug product. These attributes have not been characterized extensively in any previously approved protamine sulfate injection products. Secondary and higher order structures of monoclonal antibodies and therapeutic proteins will be determined using Circular Dichroism which will aid in complete characterization of proteins and therefore, DPQR wishes to purchase this equipment. This collaborative project between Office of Testing and Research, Office of Biotech Products and Office of Generic Drugs will be able to delineate some of the critical quality attributes (CQAs) which are important for safety and efficacy. A comprehensive characterization will help build a regulatory framework for the incoming biosimilars which will enable reviewers to look proactively into characterizing similar molecules. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capabilities are not sufficient for effective evaluation of respondents capacity to provide the Circular Dichroism Spectrometer. All offerors must be registered in the CCR located at http://www.ccr.gov. Respondents will not be notified of the results of this evaluation. TheGovernment will not entertain questions regarding this Market Research. Interested contractors must submit their responses by email, fax or mail to Roy Mutch, Contract Specialist, 60 8th Street, NE, Atlanta, GA 30309 or roy.mutch@fda.hhs.gov, on or before June 28, 2011, 1500 pm EDT. Primary Point of Contact: Roy Mutch, Contracting Office Address: FDA 60 8th Street, NE, Atlanta, GA 30309. Fax 404 253-2256.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1088717/listing.html)
- Place of Performance
- Address: FDA, BLDG 64, 10903 NEW HAMSPIRE AVENUE, SILVER, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02476762-W 20110622/110620234341-2fc7037debd228ec4ca522630979b059 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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