SOLICITATION NOTICE
66 -- Streptamer Isolation Kits
- Notice Date
- 12/7/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 18003305
- Archive Date
- 12/22/2017
- Point of Contact
- Andre M. Moody, Phone: 3014022677
- E-Mail Address
-
moodya@cc.nih.gov
(moodya@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The Government intends to award a fixed price purchase order to iba Solutions for Life Sciences, Gottingen, Germany. The CPS is responsible for the manufacture of human cells and tissue-based products utilized in phase MI clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the NIH Clinical Center. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. This is a Good manufacturing practice standard (GMP) grade reagent that is needed to support a new NCI Pediatric Oncology Branch clinical protocol, in addition to other protocols (see#5) which our lab will use to manufacture cells. This vendor is the only Supplier for this Tcm isolation kit. Patients will be treated with anti-cancer T memory stem cells (Tscm). Tscm cells have been shown to be more effective at eliminating cancer cells in patients than effector cells, which is what is traditionally given. The items requested here are to be used to specifically isolate Tscm cells from patient apheresis samples. The Streptamers are used for the isolation of naive T-cells prior to transduction with CD19 chimeric antigen receptor. The pure and label-free CD8 positive cells are subjected to a total of three (3) selections with magnetic CD62L Fab Streptamers using the sam procedure. The CD8+CD62L+T Cells are then subjected to a third positive selection with CD45RA Fab Streptamers. The resulting cell preparation is highly enriched with CD8+CD62L+CD45RA+naive T cells with purity of more than 90%. This process with designed, establised and validated using the reagent kits and the protocol #10C0054 was reviewed and approved by the FDA. Not using this kit would require that the process would have to go before the FDA regulatory agency for reapproval as no substitutions or deviations are otherwise permissible. iBA Solutions for Life Sciences is the only us distributor of the Tcm Fab Streptamer isolation kits. No other vendor has these specific streptamers or this patented technology. Lastly, not using this could prove life threatening to the patient population.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18003305/listing.html)
- Place of Performance
- Address: National Institutes of Health, 6707 Democracy Blvd., Suite 106, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04760811-W 20171209/171207231621-781fcd37c36be899e13982532727a74c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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