SOLICITATION NOTICE
68 -- 500mg of Daclizumab-CHX-A" DTPA
- Notice Date
- 4/14/2008
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80064-MM
- Point of Contact
- MelissaMarino,, Phone: 301-402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Metabolism Branch, plans to procure on a sole source basis services regarding 500mg of Daclizumab-CHX-A" DTPA for use in human patients in clinical trials with Goodwin Biotechnology, Inc., 1850 N.W. 69th Ave. Plantation, FL 33313. This acquisition will be processed under FAR Part 12, Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13 to use simplified procedures for commercial acquisitions. The North American Industry Classification System code is 325414 and the business size standard is 500 employees. The purpose of this procurement is to obtain 500mg of Daclizumab-CHX-A"DTPA for use in human patients in clinical trials performed under an existing Investigation New Drug (IND) application. The conjugated (chelated) product must be produced and vialed under Good Manufacturing Practices (GMP) conditions using FDA validated procedures, at 1mg/vial in a volume of 200uL. Contractor must deliver 500 vials for patient use. This production requires that a higher number of vials be filled in order to also provide vials required for GMP testing purposes. Contractor must provide appropriate CMC (Chemistry Manufacturing and Controls) information for an FDA IND for this product. The monoclonal antibody directed toward CD25 (humanized anti-Tac, daclizumab, Zenapax) was chelated previously under GMP conditions with the CHX-A" chelate developed at the NCIl. This chelation was performed under good manufacturing practices (GMP) by Goodwin Biotechnology. The NCI has virtually exhausted the supply of GMP CHX-A" daclizumab that is required for these clinical studies. It is critical to the ongoing clinical protocols of the NCI to obtain Daclizumab-CHX-A" It is critical for the research community that the Daclizumab-CHX-A"DTPA required by this procurement is produced in a GMP facility under GMP regulations defined by the FDA, with proper documentation provided. It is critical that the facility producing this clinical reagent have experience in the very specific process of attaching CHX-A" DTPA to a monoclonal antibody and vialing said product under GMP conditions. Goodwin Biotechnology is experienced with the complex methodology of CHX-A" chelation of a monoclonal antibody directed toward the CD25 antigen. They have an FDA certified procedure and are the only company the expertise and knowledge to perform this very specific GMP chelation. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party has the unique capabilities, resources and personnel to perform the requirement. Capability statements must be received in the contracting office by 1:00 PM EDT, on April 23, 2008. For further information please contact Melissa Marino, Contract Specialist via electronic mail at marinome@mail.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference NCI-80064-MM.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=d8c8269713a74191d5d51ff81d04da07&tab=core&_cview=1)
- Record
- SN01553713-W 20080416/080414220703-d8c8269713a74191d5d51ff81d04da07 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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