The National Institutes of Health (NIH), National Cancer Institute (NCI), Radiation Oncology Branch (ROB), Radioimmune & Inorganic Chemistry Section (RICS) is soliciting contractors to conjugate the chelate CHX-A” DTPA to the monoclonal antibody Herceptin under Good Manufacturing Practices (GMP) Conditions, and vial the Conjugated Product under GMPconditions for early Phase Clinical Trials under an Investigational New Drug (IND). The North American Industry Classification System code is 325414 and the business size standard is 500 employees. This solicitation is NOT set aside for small businesses. This item is considered commercial and is being prepared in accordance with the format in FAR Part 12. The Radioimmune & Inorganic Chemistry Section, Radiation Oncology Branch of the National Cancer Institute (NCI) is a leader in the field of developing chemistry for radioimmunotherapy and imaging and thus is instrumental in facilitating novel translational research. From laboratory experiments which investigate bifunctional chelating agents, establish stability and conjugation protocols, execute pre-clinical efficacy evaluations, and develop innovative and appropriate treatments of malignancies such as leukemia, lymphoma, and disseminated intraperitoneal diseases such as colorectal, ovarian, pancreatic cancer, and mesothelioma. The goal of this particular work is to have the monoclonal antibody Herceptin conjugated to the CHX-A” DTPA under GMP (Good Manufacturing Practices), and the conjugated product vialed under GMP for early phase clinical trials which will be performed at the NIH Clinical Center in collaboration with the Molecular Imaging Program, the Medical Oncology Branch, and Nuclear Medicine Department, CC. Genentech, the manufacturer of Herceptin, will provide the bulk of Herceptin monoclonal antibody. The CHX-A” DTPA ligand will be made in the NCI laboratory and will be shipped to the Contractor. The Standard Operating Procedure (SOP) will be listed in the Statement of Work of the RFQ. The goal is to obtain 2 grams of Herceptin-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 1mg/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. Solicitation: The RFQ must be requested by electronic mail or by fax. Telephone requests will not be accepted. Request for the RFQ shall be made to the attention of Debbie Moore, Contract Specialist via electronic mail to [email protected] . Requests shall include name of the contractor, DUNS number, telephone number, point of contact, business size standard, and identify the RFQ requested as RFQ-NCI-60011-NV on all correspondence. All questions must be in writing and can be faxed to (301) 402-4513 or emailed to [email protected] . It is the vendor's responsibility to call (301) 402-4509 to verify questions have been received. The deadline of this synopsis is December 19, 2005 at 1 PM EST. The estimated issue date of the solicitation is December 20, 2005 and the estimated due date is January 9, 2006.

Bid Protests Not Available