SOLICITATION NOTICE
B -- Stability Testing of SS1P Drug Product
- Notice Date
- 5/1/2014
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02RC42521-57
- Archive Date
- 5/30/2014
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442, Terry L. Galloway, Phone: 240-276-5384
- E-Mail Address
-
reyes.rodriguez@nih.gov, gallowaytl@mail.nih.gov
(reyes.rodriguez@nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Molecular Biology (MLB), Clinical Immunotherapy Section (CIS), plans to procure on a sole source basis testing services to monitor identity, potency and safety as required in conformance with the Food and Drug Administration's (FDA) guidelines for submission of Chemistry Manufacturing and Contrls (CMC) as part of the Investigational New Drug (IND) application from Advance Bioscience Lab, Inc. (ALB), 9800 Medical Center Drive, Bldg D, Rockville, MD 20850. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541380 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is six (6) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. NCI/CCR/MLB/CIS runs clinical trials of recombinant immunotoxins in patients with cancer and studies issues related to these Fv-toxin molecules in the research laboratory. Ongoing clinical trials include targeting CD22 and CD25 in patients with leukemia, lymphoma, and Hodgkin's disease with the recombinant immunotoxins HA-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. Contractor Technical requirements: The contractor shall: Test samples, lot FIL129J01 at 48 month time point (8/17/2014) shall be assayed along with a reference sample, provided by the NCI. Stability Assays: Required assays are shown below: Description Proposed Test Method Reference Appearance and Description ABL, TM-0008 pH ABL, TM-0013 Protein concentration by A280 ABL, TM-0004 SEC-HPLC ABL, TM-0005 SDS-PAGE, silver stain reduced ABL, TM-0003 SDS-PAGE, silver stain, non reduced ABL, TM-0003 SDS-PAGE, Coomassie, reduced ABL, TM-0003 SDS-PAGE, Coomassie, non-reduced ABL, TM-0003 Osmolality CRL, USP<785> Isoelectric focusing CRL, GP-C509 Container closure integrity Nelson Labs, STP-0149 Sterility Nelson Labs, STP-0081 Particulate matter Nelson Labs, USP<788>, STP-0011 Free (DTT) thiol content CRL, CTM-2295 Cytotoxicity* in A431K5 cell line NCI LMB* Government Responsibilities: NCI will provide the Contractor with an electronic version of stability specifications for each assay. NCI will provide the Contractor an electronic report with results from Potency assay 2 weeks after each time point above. Reporting Requirements and Deliverables: Contractor shall review completed results and compare them to stability specifications provided by NCI. Any deviation or variation observed during the execution of the assay protocols shall be documented. As stability results become available, contractor shall issue of Certificate of Analysis (CofA) for the time point and submit to NCI. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11 AM EST, on May 15, 2014. All responses and questions must be in writing and faxed to 240-276-5399 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at reyes.rodriguez@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. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC42521-57 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02RC42521-57/listing.html)
- Place of Performance
- Address: Contractor's Site, United States
- Record
- SN03354547-W 20140503/140501235504-4c8b8e6156e21b04d70f567775261031 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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