Manufacture of SS1P Drug Product

The Laboratory of Molecular Biology, Clinical Immunotherapy Program of the National Cancer Institute intends to negotiate a contract on a sole-source basis with Advanced BioSciences Laboratories, Inc. of Kensington, Maryland. The contract is for the production of SS1P immunotoxin drug product and requisite drug stability programs for Phase II clinical trials to be carried out at NIH in the Clinical Center. It is expected to be a cost-reimbursement contract for a period of 2 years. This acquisition shall complete the production of this drug which was begun under contract HHSN2612000800007. Specifically, the contractor shall 1) monitor the drug product for identity, potency and safety using a stability program consisting of a panel of assays ; 2) complete cGood Manufacturing Process of several lots of SS1P drug product; 3) review completed results at each time point and compare them to stability specifications provided; (NOTE: As stability results become available at each time point, the contractor shall issue a Certificate of Analysis for the time point and submit it to NCI.); 4) deliver the drug substance in a single lot of a least 1 mg frozen SS1 (dsFv)-PE38. Advanced BioSciences Laboratories meets the requirements of the FAR 6.302-1(a)(2), in that they are the only responsible source that will satisfy the agencies requirements without significant cost in the loss of time and materials already invested in the development of this drug. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet all the requirements, it may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient details to allow the NCI to determine if it can meet the requirements of this synopsis. The estimated period of performance is September 2008 through September 2010. Numbered Note 22 applies. Collect calls will not be accepted.