SOLICITATION NOTICE
65 -- FBS qualified for human iPS-derived T cell generation
- Notice Date
- 12/21/2017
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC85007-45
- Archive Date
- 1/19/2018
- Point of Contact
- Miguel Diaz, Phone: 2042765439
- E-Mail Address
-
miguel.diaz@nih.gov
(miguel.diaz@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- National Cancer Institute (NCI), Division of Cancer Treatment and Support Branch plans to procure, on a sole source basis, Fetal Bovine Serum (FBS) from Gemini Bioproducts, 930 Riverside Parkway West Sacramento, CA 95605. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitionist. The North American Industry Classification System code is 325414 and the business size standard is 1,250 employees. It has been determined there are no opportunities to acquire green products or services for this procurement. The National Cancer Institute (NCI), Office of Acquisitions, Treatment and Support Branch has a requirement to purchase 600 bottles of Fetal Bovine Serum (FBS) on behalf of the NCI Surgery Branch (SB). FBS is the blood fraction remaining after the natural coagulation of blood, followed by centrifugation to remove any remaining red blood cells. FBS is the most widely used serum-supplement for the in vitro cell culture of eukaryotic cells. This is due to it having a very low level of antibodies and containing more growth factors, allowing for versatility in many different cell culture applications. This is a commercial item that is critical to support ongoing high priority research projects focused into the rejuvenation of patient cancer antigen specific Tumor Infiltrating Lymphocytes (TIL). This serum is essential to develop novel immunotherapies for the treatment of patients with a variety of malignancies that include melanoma, gastrointestinal, lung, and bladder cancer. This serum will be used to substain the in vitro differentiation of human induced pluripotent stem cells (hiPSC) generated from TIL into cancer antigen specific T cells that is essential for carrying out ongoing high priority projects to develop more potent T cells with therapeutic properties against a variety of malignancies. The government anticipates issuing one, fixed price award to one vendor for the purchase of 600 bottles of FBS (500mL per bottle). Currently, NCI SB relies on very limited amount of FBS qualified to generate T cells from human iPSC. Prior to the purchase of the current lot of FBS, several lots of FBS needed to be tested to find one that can qualify with several conditions including, able to expand human and murine mesenchymal stem cells in vitro, able to differentiate human iPSC into hematopoietic progenitors, able to differentiate iPSC-derived hematopoietic progenitors into double positive T cells and able to sustain the long term culture of human T cells. To find one lot that matches with our requirements, the validation process takes around 4 months. In our experience from an average of 20 different lots only one qualifies with all our requirements. Moreover, since FBS is a commercial product produced in limited amount per lot, it is difficult to obtain large quantities of an optimal FBS, compromising the reproducibility of our experiments and additionally involving extensive resources to identify a new lot capable of sustaining the cell culture. Therefore, NCI SB requires the large purchase of a complete lot of FBS that has the previously determined properties, in order to minimize experimental and human resources costs and improve the quality of the research. Compatibility requirements with existing current experiments and cell culture systems is necessary to ensure the reproducibility of our experimental results. First, the NCI SB must be sure that murine and human mesenchymal stem cells, which are used as feeder cells, can be expanded long term (at least 1 month) without losing their normal growth rate and their physiological potential to support differentiation of hiPSC into mesodermal, hematopoietic and T cell lineage (60-70 days in total). The FBS also has to be evaluated to sustain the long term differentiation (up to 60-70 days) of hiPSC in vitro. Finally, the lots have to test negative for toxic effects in human and murine T cell culture and expansion. Current state of art alternatives to the use of an animal source serum of variable origin are available, however they are characterized for the low reproducibility and high cost of reagents. To develop a robust methodology to rejuvenate T cells in vitro using TIL-derived iPSC as a source, it would be necessary to continue researching using a high experimental-replicable system which this FBS can offer. Otherwise, NCI would risk jeopardize data and compromise biological sources accumulated for years in the branch. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response 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. Responses must be received in the contracting office by 4 PM ET, on January 3, 208. All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@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. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02RC85007-45 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC85007-45/listing.html)
- Record
- SN04773405-W 20171223/171221231058-d7b6ae92d0dd14ed0735136a78bff13a (fbodaily.com)
- Source
-
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