SOURCES SOUGHT
66 -- Quantum Cell Expansion System
- Notice Date
- 8/3/2011
- 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)-2011-246-JML
- Archive Date
- 8/23/2011
- 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 Quantum Cell Expansion System. 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. 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 needed. CaridianBCT has 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. Specifications The Quantum System delivers: -Scalability for increased cell expansion capability while limiting the required manual labor; -Automation for easy and consistent cell loading, media exchange, and cell harvest; -Reduction in contamination potential via closed cell culture methodologies; and, -Customization of automated tasks. 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 August 8, 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)-2011-246-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health/NIDCR, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02520031-W 20110805/110803235222-a3e6bb036ffc9896ece9b28bf41e4037 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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