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FBO DAILY ISSUE OF SEPTEMBER 03, 2010 FBO #3205
SOLICITATION NOTICE

66 -- Brand name Miltenyi Biotech AutoMACS Pro Separator

Notice Date
9/1/2010
 
Notice Type
Presolicitation
 
NAICS
333314 — Optical Instrument and Lens 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-100225-AV
 
Archive Date
10/1/2010
 
Point of Contact
Ashley L. Virts,
 
E-Mail Address
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
The National Cancer Institute (NCI), Center for Cancer Research (CCR), Experimental Transplantation and Immunology Branch (ETIB) plans to procure on a sole source basis the brand name Miltenyi Biotech AutoMACS Pro Separator from Miltenyi Biotec, Inc., 2303 Lindbergh Street, Auburn, CA 95602-9027. This acquisition will be processed under the procedures for 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 acquisitions. The North American Industry Classification System code is 333314 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: One week from date of award. The acquisition of the proposed Miltenyi Biotec AutoMACS Pro Separator will allow the NCI to replace an obsolete Miltenyi Biotec AutoMACS Classic Separator (s/n 0210) that has been in use for 10 years and is near its expected operational lifetime. The Miltenyi Biotec AutoMACS Pro Separator represents a next generation device to facilitate the isolation of hematopoietic stem cells. The existing Miltenyi Biotec AutoMACS Classic Separator has been used by several investigators in the NCI Experimental Transplantation and Immunology Branch for several years, and has been cited in several publications, including Nature Medicine. The advantage of the Miltenyi Biotec family of Separators (AutoMACS, CliniMACS) is the use of small paramagnetic particles for non-toxic cell separations. The AutoMACS Pro is current technology and changing vendors or technologies would alter scientific results. This platform is the same platform supported in the clinic (NCI uses a CliniMACS in the clinic for pediatric work); thus pre-clinical work conducted on this platform (non-toxic, biodegradable micro-beads) is directly translatable to clinical procedures. The Government will trade in the Miltenyi Biotec AutoMACS Classic Separator that is presently installed at the NCI with purchase of the new instrument. The following salient characteristics apply to the Miltenyi Biotec AutoMACS Pro Separator:  barcode reader ("code reader") or touch screen activated automated cell isolation system with pre-programmed isolation protocols that are utilized by the integrated computer  sequential separation and labeling of up to six samples without user intervention for both negative and positive selection  six samples can consist of both manually and auto-labeled cells  custom cooling sample rack to keep samples cool during the separation process  reagents used for auto-labeling are the same as used for manual protocols using MACS Reagents  system uses biodegradable 50 nm super-paramagnetic MicroBeads (iron) coated with polysaccharide that form a colloidal suspension  MicroBeads are directly conjugated to monoclonal antibodies  separation time of 3-10 minutes, depending on the program  input volume of 100 ul to 50 ml  automated system cleaning  patented columns: dual super-paramagnetic, bio-Teflon® coated matrix columns that are reusable over a two week period or up to 100 separations, whichever comes first  high-gradient magnetic field optimized for cell isolation while maintaining optimal cell viability and function  sensitivity: highly pure selection and recoveries of very rare populations, frequencies down to 1 in 10 billion. The only device currently available to sort hematopoietic stem cells (CD34+ cells) for clinical trials is the Miltenyi CliniMACS Separator, of which the CliniMACS components (Reagents, Tubing Sets, Instruments and PBS/EDTA Buffer) are available for use under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE). The NIH Clinical Center, Department of Transfusion Medicine (DTM) provides clinical services to support NIH patients in need of blood component therapy, cellular therapy, therapeutic apheresis, and specialized laboratory diagnostics. DTM uses a CliniMACS Separator for isolation of CD34+ hematopoietic stem cells. Therefore, the Miltenyi AutoMACS Pro Separator is the only available instrument to provide direct transition and translation with protocols and reagents, between pre-clinical work and clinical protocols at the NIH. Other vendors do not provide the applicable reagents and/or reagents for this translation. As the sole manufacturer and distributor of the Miltenyi Biotech AutoMACS Pro Separator, Miltenyi Biotech, Inc. is the only known source that can provide this equipment. 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 September 16, 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 Ashley Virts, Contract Specialist at virtsa@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-100225-AV on all correspondences.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-100225-AV/listing.html)
 
Record
SN02263882-W 20100903/100901235450-fc3f02b464b48b5634d7ee158e6273f2 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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