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: Fenwal, Inc., Lake Zurich, IL 60047.
The Cell Processing Section (CPS) is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. Also, regarding Institute research support it: 1)Develops biologics collection and manufacturing processes to support clinical trials, 2) Collects, manufactures and distribute blood components for in vitro research use, 3) Collaboration in the design, planning, execution and data analysis of clinical studies, 4) Collects and manufacture specialized cellular products to support clinical trials and, 5) Develops and evaluate assays for clinical application and biologics safety testing and cellular characterization.
Cell washing and concentration is needed to remove supernatant from target cells. The LOVO is an automated system, using spinning membrane technology, which produces at a higher volume, has a faster flow rate and closed system. It is the only system that allows for processing volume from 50ml to 15 liters. CPS has already completed the validation and qualification on the LOVO instrument currently used in CPS. CPS staff is also already trained in LOVO usage. CPS also currently has a contract for preventive maintenance for the existing LOVO.
Primary supplies sought:
Catalog Number: Description: Quantity:
6R4900 LOVO Instrument 1 each
0212551465 Weight Set & Case 1 each
The instruments must be specifically designed to wash and concentrate cells in a closed system, and it should prevent the contamination of the processed cells with microbes such as bacteria and fungi. The instruments should process large quantities of cells up to 10 billion cells or more. The instrument is automatic system for cells concentration and cell washing, it also has auto dilution feature that help reduces the error will occur during processing and save a lot of staff time. The instrument must also be equipped with software which documents the identification of the product processed and the washing parameters.

- System enables closed system processing
- Automated Cell Processing System
- A spinning membrane must have 4 micro meter pore size and 12mL internal volume capacity or equivalent
- The volume range 100mL to 2500mL for large quantities processed
- Software for auto dilution for large cells volume
- Product estimator software capability for each parameters
- Product estimator software capability for each parameters

 

 

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