36 & 48 Month Stability Testing of SS1P Drug Product

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive Room 1E154 Bethesda, MD 20892 Description: The Laboratory of Molecular Biology's (LMB) Clinical Immunotherapy Program (CIS), Center for Cancer Research (CCR), National Cancer Institute (NCI) plans to procure on a sole source basis to Advanced Bioscience Laboratories Inc. (ABL) services to perform the 36 & 48 month stability program on SS1P drug product. The services herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1). The North American Industry Classification System code is 541380 and the small business standard is $14 million. Only one (1) award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. The Laboratory of Molecular Biology (LMB) Clinical Immunotherapy Section (CIS) runs clinical trials of recombinant immunotoxins in patients with cancer and studies issues related to these Fv-toxin molecules in the lab. Ongoing clinical trials include targeting CD22 and CD25 in patients with leukemia, lymphoma, and Hodgkin's disease with the recombinant immunotoxins BL-22 and LMB-2, both of which have induced complete remissions; and targeting the antigens Lewis-y and mesothelin (SS1PE38) on solid tumors (carcinomas). Laboratory projects deal with mechanisms of toxin effectiveness and action, and also study mechanisms and prevention of toxicity to normal tissues. SS1(dsFv)-PE38 (SS1P), is composed of SS1, a single-chain antibody that binds tightly to mesothelin, and PE38, the translocating and ADP-ribosylating segments of the Pseudomonas exotoxin (PE) protein. PE can kill cells if it gains entry into cells. Anti-mesothelin immunotoxin SS1P is designed to attach to mesothelin on the cancer cells and allow entry of PE38, which will then destroy the cells. Drugs that are used in humans must be monitored for identity, purity and potency (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline Q5C "Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products"). Collectively this is known as a stability program. Stability programs must be conducted under "Current Good Manufacturing Practices" (cGMP). This entails using a qualified laboratory and validated assays. The NCI is responsible for the SS1P drug product stability program and has an Investigational New Drug (IND) application on file with the Federal Drug Administration (FDA). The LMB Clinical Immunotherapy Program has several immunotoxins in clinical trials to treat cancer patients. SS1P drug product is undergoing clinical trials. Drugs in clinical trials are required to be monitored for identity, potency and safety. The LMB requires qualified, documented stability assays in conformance with the Food and Drug Administration's (FDA) guidelines for submission of Chemistry Manufacturing and Controls (CMC) as part of the Investigational New Drug (IND) application. NCI will provide the Contractor with stability specifications for each assay. NCI will provide vendor with results from Potency assay 2 weeks after each time point. The Contractor will review completed results and compare them to stability specifications provided by NCI. Any deviation or variation observed during the execution of the assay protocols will be documented. As stability results become available, the Contractor will issue a Certificate of Analysis for the time point and submit to NCI. Except for the Potency Assay, all assays will be performed at the contractor's facility. ABL is uniquely qualified to perform the SS1P Stability Program as they have the infrastructure need to perform the assay tests and have validated the assays in accordance with the NCI Standard Operating Procedures (SOP). A new contractor will need to test the assays repeatedly to ensure they are reproducible, accurate and precise, which will be duplicative costs on the Government and cause a delay to the program. In addition, a change in contractor may introduce problems with consistency in the assay and their subsequent analysis. The IND application on file with the FDA has been setup to perform the SS1P Stability Program with ABL. Changing contractors will require a modification to the application. In order for this to occur, the new contractor will need to be audited by a third party. ABL has been audited by a third party and found to meet the regulatory requirements needed for this program. This is not a solicitation for competitive quotations. However, if any interested party, particularly small businesses, believe they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office on or before 11:00 AM EST on June 06, 2013. No electronic capability statements will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI contracting office to the address stated above. All questions must be in writing and can be faxed (240)-276-5401 or emailed to Anh-Huy Nguyen, Contract Specialist at contact@example.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference solicitation number NCI-130068-HN on all correspondences.