SOLICITATION NOTICE
66 -- Miltenyi Biotec CliniMACS Tubing Set; CliniMACS PBS/EDTA Buffer; CliniMACS CD8 (CRR)
- Notice Date
- 3/3/2009
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90067-AV
- Archive Date
- 3/28/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Clinical Research Center (CRC), Surgery Branch plans to procure on a sole source basis, the brand name CliniMACS Tubing Set (200-073-105); CliniMACS PBS/EDTA Buffer (200-070-026); CliniMACS CD8 CRR (200-070-215) with Miltenyi Biotec Inc.; 12740 Earhart Ave.; Auburn, CA 95602. The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106-1 (b) (1). The North American Industry Classification System Code is 541711 the business size standard is 6.5 M employees. Delivery Date: approximately 90 days from date of award. The use of a patient's own lymphocytes as a treatment for metastatic cancer is an approach that is being actively pursued in clinical trials in the Surgery Branch, NCI. Current and recent clinical results indicate that these cell transfer therapies are among the most effective treatments known for certain patients. Ongoing protocols on the Surgery Branch are investigating the use of subsets of TI L to improve and extend this therapy approach. The Cell Production Facility of the Surgery Branch, NCI, is required during the production of each patient-specific cell treatment to adhere exactly to the standard operating procedures, including the exclusive use of approved reagents and materials. Each protocol requires a separate, FDA approved, Investigational New Drug (IND) application that is held either by the Surgery Branch or the Cancer Therapy Evaluation Program (CTEP). Each cell based treatment is approved by the Clinical Center and the Food and Drug Administration (FDA) based on a detailed and formalized protocol. The only available clinical grade system for these studies is the Miltenyi CliniMACS apparatus and associated GMP-approved magnetic beads. The Surgery Branch has undertaken extensive preclinical validation and optimization using the Miltenyi apparatus for the reagent requested (CD8 microbeads) and included detailed protocols in the IND applications. The aforementioned critical clinical-grade reagents are required for the clinical protocols within the Surgery Branch of the NCI and are manufactured and distributed solely by Miltenyi Biotec Inc. The reagents are required for use under multiple clinical protocols conducted by the Surgery branch, approved by the IRB and FDA, and included as part of the following IND# BB-8709. No other source is known to the NCI who is capable of supplying the necessary reagents to the lab. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the researcher to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on March 13, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Ashley Virts: virtsa@mail.nih.gov. It is the vendor’s responsibility to ensure questions have been received. 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, contractor must have valid, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-90067-AV on all correspondence.
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