SOURCES SOUGHT
65 -- Keyhole Limpet Hemocyanin P168371
- Notice Date
- 12/10/2009
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- NIHCL2010053
- Point of Contact
- Brian J. Lind, Phone: 301-402-0735
- E-Mail Address
-
LindBJ@cc.nih.gov
(LindBJ@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH) Clinical Center Pharmacy Department is conducting a market survey to determine the availability and technical capability of qualified small businesses, including (8A) small businesses or HUBZone small businesses capable of providing Keyhole Limpet Hemocyanin (KLH). with the following specifications: Stellar Biotechnologies, Inc- 415 High Molecular Weight Keyhole Limpet Hemocyanin. This material is required to support ongoing clinical trials with multiple previously submitted Investigational New Drug (IND) applications with the Food and Drug Administration (FDA). Any change in the source of the material would require new analytical assays to be developed, new formulations to be produced, new IND's to be filed with the FDA, and would have a negative impact on the evaluation of data already generated from the ongoing trials. There are 3 ongoing NIH protocols using this substance, each with a separate IND describing the use and character of this sterile product. The Keyhole Limpet is a type of sea urchin and the Hemocyanin is a constituent of the sea urchin's blood which has been extracted in a certain way. There are differences in the activity of different colonies of Limpets and so, it is important for the integrity of the studies to get the KLH from the same source. The FDA is aware of the importance of this control factor in the ongoing protocols. The Keyhole Limpet Hemocyanin MUST MEET the following requirements; 1. The product shall have an extensive safety record and meet all FDA guidelines for use in clinical trials. The FDA currently requires pathogen testing of KLH for the viruses, Hepatitis A, Norwalk and Rotavirus and the bacterium Vibrio cholera. Vendor must supply data that the KLH is free of Hepatitis A, Norwalk and Rotavirus and Vibrio. The testing shall be included on the Certificate of Analysis for every lot of KLH provided. 2. Because of the processes in place for harvesting and purifying the KLH which prohibit denaturation, the KLH which is currently being used in the protocols is more potent than that of other products available. The denatured subunit of KLH is a glycoprotein with a molecular weight of 400-450,000 daltons while the native form of KLH is a dodecamer which consists of 20 subunits of KLH with a molecular weight of 8 - 9,000,000 daltons. In the natural Hemocyanin product at least 50% of the KLH exists as a dodecamer and the remainder can be found as dodecamer aggregates. 3. Our current KLH is purified as a native molecule and meets the molecular weight 8 - 9,000,000 standards. None of the KLH is detectable as being degraded or existing in its subunit form. This native form renders the KLH more potent immunologically than products containing degraded KLH. 4. The formulation of the currently used KLH product already includes a solution in a physiological buffer eliminating some waste associated with reconstitution of the lyophilized KLH since some denatured KLH is rendered insoluble by lyophilization. 5. The material being used is harvested in a humane manner from Limpets contained on premises whereas other manufacturers use "wild" Limpets which are returned to the ocean and therefore unable to demonstrate that the Limpets survive the exsanguinations process. Specifically, for these ongoing protocols the crude material is only harvested from Limpets that are identified and tagged. This Hemocyanin is removed in a non-lethal manner from Limpets and they are then returned to the water. Records are kept indicating when and how each Limpet has been harvested and the fate of each Limpet after it is returned to the water. After sufficient recovery times, these Limpets can be reused for harvesting more Hemocyanin. The forms of KLH (KLH1 and KLH 2 present in approximately a 60 to 40 ratio in the native state) are monitored to assure that the animals have recovered and are producing the native form of the molecule. This provides a large, renewable source of the crude material. It is critical to the integrity of the protocols and the ongoing research that the KLH be from the current supply source previously used in the ongoing trials. Offerors must provide descriptive literature or other materials that demonstrates their ability to meet the forgoing requirements. Firms with the capability of providing the required supplies listed above are required to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502(b) whether or not this procurement will be set aside for any of the programs described above. The intended procurement will be classified under the North American Industrial Classification (NAIC) code 325411 with a size standard of 750 employees. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills, and capability to fulfill the Governments requirements above. The capability statement should not exceed 15 pages and be in sufficient detail so that the Government can determine the experience of your firm to provide the requirements above. Capability statement must be received at the address identified in the synopsis prior to the close of business (4:30 PM local time at designated location) on December 24, 2009. This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for any cost incurred in responding to this market survey and is not to be construed as a commitment by the Government, or will the Government pay for any solicitations.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIHCL2010053/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, 10 Center Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02021037-W 20091212/091210234837-ab8629d62b3c6063c6d13e2f4d9eb71d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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