SOLICITATION NOTICE
H -- Testing Services for the Chelation of the Monoclonal Antibody 7G7/B6
- Notice Date
- 7/25/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-30099-NG
- Response Due
- 8/20/2003
- Archive Date
- 9/4/2003
- Point of Contact
- Malinda Holdcraft, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Caren Rasmussen, Lead Contract Specialist, Phone (301) 402-4509, Fax (301) 402-4513,
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
- Description
- The National Institutes of Health (NIH), National Cancer Institute (NCI), Metabolism Branch is soliciting contractors to provide laboratory manufacturing and associated testing services for the Chelation of the Monoclonal Antibody 7G7/B6 (to the IL-2alpha subunit receptor) to CHX-A? DTPA under Good Manufacturing Practices (GMP) Conditions, and Vialing of the Conjugated Product under GMP for Phase I Clinical Trials under an Investigational New Drug (IND). The North American Industry Classification System code is 541380 and the business size standard is $6M. This item is considered commercial and is being prepared in accordance with the format in FAR Part 12. The Metabolism Branch has developed and continues to develop innovative treatments for leukemia, lymphoma and other IL-2R expressing diseases. The goal of this particular work is to have the monoclonal antibody 7G7/B6(to the IL-2Ralpha receptor) chelated to CHX-A? DTPA under GMP, and the conjugated product vialed under GMP for Phase I clinical trials which will be performed at the NIH Clinical Center. NCI will provide the bulk 7G7/B6 monoclonal antibody which was GMP produced in the NCI contract facility located in Frederick, Maryland, and is currently stored under GMP conditions. The CHX-A? DTPA ligand will be made under Good Laboratory Practices (GLP) in the NCI laboratory and shipped by NCI to the contractor. Standard Operating Procedures (SOP) will be listed in the Statement of Work. Our goal is to obtain 500mg of 7G7/B6-CHX-A? DTPA for use in patients in clinical trials performed under an IND. Conjugated product must be produced and vialed under GMP conditions at 1 mg/vial in a volume of 200uL. To deliver 500 vials for patient use requires a higher number of vials be filled in order to also provide vials required for GMP testing purposes. Request for Quotation# RFQ-NCI-30099-NG will be issued on 7 Aug 03 with responses due on 20 Aug 03, 1:00 p.m. EDT (local Washington, D.C. time). Sources requesting a copy of the solicitation package are required to submit a written request to the address indicated above. Requests may be emailed to Malinda Holdcraft, Purchasing Agent at holdcram@exchange.nih.gov or by fax 301-402-4513. No telephone requests for solicitation packages will be accepted. All interested parties are to submit one (1) original copy to the following address: Malinda Holdcraft, Purchasing Agent, NIH/NCI/RCB, 6120 Executive Blvd., Room 6072, Rockville, Maryland 20852-7194.
- Record
- SN00382964-W 20030727/030726120526 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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