SOLICITATION NOTICE
66 -- Quantum Cell Cartridges
- Notice Date
- 9/12/2011
- Notice Type
- Presolicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(DE)-2011-360-JML
- Archive Date
- 10/1/2011
- Point of Contact
- Jonathan M. Lear, Phone: 3014514470
- E-Mail Address
-
learj@nhlbi.nih.gov
(learj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR QUOTE. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND QUOTES WILL NOT BE REQUESTED. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA), on behalf of the National Institute of Dental and Craniofacial Research (NIDCR), intends to negotiate and award a purchase order on a noncompetitive sole source basis to CaridianBCT, Inc., 10811 W. Collins Avenue, Lakewood, CO 80215-4440 to provide the following to the NIH Bone Marrow Stromal Cell Transplantation Center: -Quantum Cell Expansion Cartridges/Sets The NIH Bone Marrow Stromal Cell Transplantation Center is in the process of the final stages of validation for the manufacture process for the isolation and expansion of Clinical Grade Bone Marrow Stromal Cells (BMSCs) with Protocol 10-CC-0053, "Collection of Bone Marrow from Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products." These cells will be used to treat Clinical Center patients enrolled in Institute patient treatment protocols. The process of obtaining FDA approval for the administration of these cells for patients requires that the NIH Bone Marrow Stromal Cell Transplant Center create and file a Drug Master file with the FDA. This Drug Master File requires approval by the FDA as well. Safety of the final product is the first priority for the FDA. For the culture of therapeutic doses of cells, BMSCs require a wide surface area that leads to the use of large number of simple culture flasks. These culture flasks can be used to easily produce BMSCs in a nearly closed system, thus greatly reducing the number of flasks needed. To increase compliance, safety, and traceability, a fully closed and automated system is used. CaridianBCT developed the Quantum Cell Expansion System, a fully automated bioreactor based on hollow-fiber technology that can allow for a large expansion of BMSCs. This new technology brings automation, a closed environment, and process reproducibility to those expanding cell populations for research, clinical trials, and commercial cell therapies. The sole source determination is based on the fact that these cartridges are for growing clinical grade bone marrow stromal cells for the CaridianBCT Quantum Cell Expansion System. Due to compatibility, no other company can provide cartridges that fit into the system. The delivery point is the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), Bethesda, Maryland. The North American Industry Classification System (NAICS) Code is 339112, Surgical and Medical Instrument Manufacturing, with a small business size standard of 500 employees. However, this acquisition is not set-aside for small businesses. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-53 (August 4, 2011). Interested parties may identify their interest and capabilities in response to this synopsis by September 16, 2011 at 12:00pm Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurements. Inquiries to this announcement, referencing synopsis number NHLBI-CSB-(DE)-2011-360-JML, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan Lear. Responses may be submitted electronically to learj@nhlbi.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(DE)-2011-360-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health/NIDCR, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02572510-W 20110914/110913000042-09f16346419e19928f7a93f395b5d204 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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