MODIFICATION
66 -- COBE 2991 Cell Processor for Adoptive Immunotherapy Protocols
- Notice Date
- 12/2/2010
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-110014-KM
- Archive Date
- 1/1/2011
- Point of Contact
- Karri L. Mares, Phone: 3014357774, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
maresk@mail.nih.gov, cr214i@nih.gov
(maresk@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- **Modified to add a close time of 11:00am on 12/17/10 Description The National Cancer Institute (NCI), Surgery Branch (SB), Cancer Center Research (CCR), Cell Production Laboratory (CPL) plans to procure on a sole source basis the brand name COBE 2991 Cell Processor from CaridianBCT; 10810 W. Collins Avenue; Lakewood, CO 80215. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 334516 and the business size standard is 500 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Delivery Date: 90 days from date of award. The Surgery Branch, National Cancer Institute (SB/NCI) has an ongoing clinical program using adoptive cell transfer therapy for the treatment of patients with metastatic cancer. The cell production laboratory uses a number of techniques to identify and purify tumor reactive T lymphocytes from patients with advanced cancer. In order to achieve this, the NCI must only use reagents and protocols that meet the good manufacturing practices (GMP) standards required by the FDA for the production of patient cells. This device will support the following clinical protocols (07-C-0176, 08-C-0055, 08-C-0056, 08-C-0121, 09-C-0082, 10-C-0117, 10-C-0166, 11-C-0011 and 11-C-00113). These protocols require the patients’ cells to be harvested and washed rapidly in a closed system device. The following salient characteristics apply to the COBE 2991 Cell Processor: Ability to achieve concentrate and wash 10 liters of patient cells in less than 90 minutes Ability to process the large number of cells that are required for the NCI’s clinical protocols (1x10 8 to 3x10 11 ) Must allow the concentration and washing of cells in a manner compliant with good manufacturing practices (GMP) Must be a closed/fully automated system, eliminating user errors Supplier must have supplied master files to the Food & Drug Administration (FDA) for further GMP compliance The COBE 2991 Cell Processor from CaridianBCT is the industry standard closed system device for cell processing applications in blood banks and cell therapy centers. The COBE 2991 is able to perform multiple cell processing applications on a single programmable platform. Currently no other device is marketed that meets the NCI’s cell processing needs. CaridianBCT is the sole manufacturer and supplier of the COBE 2991 cell processor and all related disposable products required to operate this device. In addition this company has Master Files, filed with the FDA that can be cross referenced for the use of its equipment and disposable items. This proprietary device is only supplied by CaridianBCT. CaridianBCT have developed protocols that are recognized by both blood banks and cell therapy centers that can be readily adapted for our needs. No other comparable machine known to the NCI is manufactured. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received at the NCI Office of Acquisitions on or before 11:00 AM EST on December 17, 2010. No electronic capability statements will be accepted (i.e. email or fax), an original and one copy must be sent to the NCI Office of Acquisitions to the address stated above. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Karri Mares, Contract Specialist at maresk@mail.nih.gov. A determination by the Government not to compete this proposed contract 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 have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-110014-KM on all correspondences.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-110014-KM/listing.html)
- Record
- SN02337259-W 20101204/101202234219-ec48bc3dc5f57b8aa06a5592401ac7c8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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