SOURCES SOUGHT
65 -- COBE 2991 Blood Cell Processor
- Notice Date
- 7/7/2011
- Notice Type
- Sources Sought
- 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)-2011-243-JML
- Archive Date
- 7/26/2011
- 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 Sources Sought (SS) Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI) on behalf of the National Institute of Dental and Craniofacial Research (NIDCR). The purpose of this SS is to identify qualified small business concerns, including Small Disadvantaged Businesses (SDB), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB), and Service-Disabled Veteran-Owned Small Businesses (SDVOSB) that are interested in and capable of providing the CaridianBCT COBE 2991 Blood Cell Processor in accordance with the below specifications. The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible small business concerns, particularly Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB), and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] under the North American Industry Classification System (NAICS) code 339112 with a size standard of 500. Based on the responses received from this SOURCES SOUGHT announcement, the proposed acquisition may be solicited as a Total Small Business Set-Aside. All eligible small business concerns responding to this Sources Sought announcement must have the capabilities to provide the below product within 60 days after receipt of purchase order. Background Information 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. Since the manufacturing process of the BMSCs involves the expansion of the cells in media containing fetal bovine serum, the Center was required to ensure that the final BMSC product was adequately washed prior to cryopreservation or infusion, and that the efficiency of the washing procedure be evaluated through a specific ELISA test and results presented as part of the Drug Master file. The CaridianBCT COBE 2991 Blood Cell Processor was used for washing and concentrating the BMSCs using a standard operating procedure developed in the Center. Validation studies performed in the laboratory showed the results of BMSCs concentration and washing met all criteria. The results of this validation were included in the Drug Master file and have been approved by the FDA. To increase the processing capacity and maintain consistency in BMSCs concentration and washing, another COBE 2991 Blood Cell Processor is required with the below specifications: Specifications •Variable spin times and speeds allow separation of components through centrifugation; •The agitate mode washes desired cell components with a choice of solutions; •Fluids or cells are expressed by the action of hydraulic fluid against a flexible membrane; •Centrifuge unit with a flexible diaphragm; •Hydraulic system; •Operator panel with program board; •5 pinch valves; •Red cell detector; •Secondary control panel; •Centrifuge cover interlock latch system; •Three operations per cycle (start/spin, supernatant-out, agitate/wash-in); •Precise programming of variable spin times adds automated accuracy and time-savings; •Programmable memory stores up to 10 protocols, with the ability to make changes during procedures for increased flexibility; •Three stop options; •Separation of product components based on specific gravities; •Removal and/or collection of desired fraction; and, •Addition and agitation of wash solutions to remove unwanted cells, debris and fluids. Interested parties should submit a tailored capability statement for this requirement, not to exceed 10 single-sided pages (including all attachments) presented in single-space and using a 12-point font size minimum, that clearly details the ability to provide this equipment. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Jonathan Lear, Contract Specialist, at learj@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), by July 11, 2011, 12:00pm, EST. All responses must be received by the specified due date and time in order to be considered.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(DE)-2011-243-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health/NIDCR, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Record
- SN02491836-W 20110709/110707235017-2f45c3a1f55c3401cac598551bea71bd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |