SOLICITATION NOTICE
66 -- GatheRex Closed System
- Notice Date
- 4/5/2018
- 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
- 18-008083
- Archive Date
- 4/20/2018
- 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
- The Cell Processing Section (CPS) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CPS operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CPS manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. Catalog Number: 80000E Description: GatheRex Closed System Liquid Handling Pump Quantity: 1 each GatheRex is currently a need for automation to concentrate and collect cells for clinical use. The GatheRex is a liquid handling device that is designed to work with G-Rex cell culture devices in order to provide customers with the ability to manufacture cells in a strict cGMP setting. The GatheRex has been adapted for the G-Rex devices to work in a closed system format. The GatheRex connects to the closed system device and uses a forced air mechanism to remove media, thereby concentrating the cells and significantly minimizes storage and/or downstream processing. An air pump pressurizes the system by pumping air through the sterile vent filter on the G-Rex device. When pressurized, the excess media or cell fraction is forced out of the device, through the tubing assembly, and into a collection receptacle. The GatheRex instrument is currently the only known instrument that can provide concentration and harvesting of cells from the GREX culture containers.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-008083/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
- SN04879989-W 20180407/180405231436-7927c78784218ebd5e0681a4814db4a5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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