SOLICITATION NOTICE
68 -- Montanide ISA 51 VG cGMP
- Notice Date
- 11/23/2005
- Notice Type
- Solicitation Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-60008-NG
- Response Due
- 12/9/2005
- Archive Date
- 12/24/2005
- Description
- The National Cancer Institute (NCI) Pharmaceutical Management Branch (PMB) plans to procure Montanide ISA-51 VG (cGMP-grade) from the sole manufacturer, Seppic, Inc. Suite 210, 30 Two Bridges Road, Fairfield, New Jersey 07004. The supplies and services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13. The North American Industry Classification System code is 325412 and the business size standard is 500 employees. The Pharmaceutical Management Branch currently provides Montanide ISA-51 Sterile Injection, 3 mL ampules for twenty-six studies involving hundreds of study participants. This is an agent that is not approved for commercial distribution in the United States and is not commercially available. Montanide ISA 51 VG is needed to support ongoing and new clinical studies. This agent is being studied as an adjuvant to other agents in various types of cancer. Montanide ISA -51 VG Sterile Injection, 3 mL vial is an agent which is intended to boost immune reactions to other experimental peptides. There are no generic equivalents, nor are there therapeutically equivalent agents that could be used in its place. The product shall be manufactured in accordance with cGMP and ICH guidelines for suitability for human use and meet all required USP (United States Pharmacopeia) and EU (European Union) criteria for acceptability in relation to final drug product QC testing. The product should be delivered within 72 hours of ordering. Montanide ISA 51 VG shall have an expiration date of not less than twelve (12) months, and preferably not less than eighteen (18) months, at the time of delivery to the NCI and all vials in each shipment shall be from the same lot. A Certificate of Analysis (CoA) shall be provided and the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), NCI must have authority to reference the company?s Certificate of Analysis, quality control data and the company?s FDA Drug Master File for the DCTD-sponsored IND(s). Changing variables at this time, with respect to chemical consistency, would be detrimental to the experiments in progress. Period of Performance: The requirement will be an indefinite delivery, indefinite quantity (IDIQ) type contract for twelve (12) months only. Seppic, Inc. is the only known source to the NCI that can provide the aforementioned substance. This substance is involved in patient care, therefore must remain consistent with ongoing treatment. This notice 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 NCI to determine if the party can perform the requirement. Capability statements must be received in the contracting office by 1:00 PM EST, on December 9, 2005. For further information please contact Malinda Holdcraft, Purchasing Agent via electronic mail at holdcram@exchange.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. Please reference NCI-60008-NG on all correspondence.
- Place of Performance
- Address: NIH
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00936884-W 20051125/051123211710 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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