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FBO DAILY ISSUE OF MAY 25, 2011 FBO #3469
SOURCES SOUGHT

66 -- Fast Protein Liquid Chromatography System (FPLC)

Notice Date
5/23/2011
 
Notice Type
Sources Sought
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 
ZIP Code
72079
 
Solicitation Number
1087217
 
Archive Date
6/22/2011
 
Point of Contact
Marcia O Park, Phone: (870) 543-7405
 
E-Mail Address
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the equipment described below. The study of safety aspects of monoclonal antibody manufacturing has been ongoing for the past 11 years. The research has consisted of both upstream cell cultures to produce the antibody as well as downstream purification processing. The majority of the downstream processing has involved the use of a Fast Protein Liquid Chromatography System (FPLC) to purify products across columns. For the past 10 years AKTA equipment has been used on a daily basis but the equipment is now failing and cannot be serviced so it must be replaced. Projects planned for the near future include looking at various effects of buffers on viral clearance capabilities of affinity and ion exchange resins. The new FPLC will be needed to aid in the purification of > 5 liters of bioreactor harvested cell culture on a regular basis. The FPLC System Equipment shall include the following:. Unicorn Software (version 6.0 or later) for transfer of all method files. An integrated fraction collector with cooling feature. Both a buffer pump and a sample pump. Ability to pump up to 25 mls/min at equal to or greater than 10MPa pressure. Capability to run up to 5 separate buffers in one method (i.e., buffer selection valves). Outlet valve with minimum of 5 options to send fluid. Integrated conductivity, UV, pH, and pressure meters/sensors. Must be compatible with current AKTA accessories, including tubing and fittings. software shall have a built-in Design of Experiment tool. Computer and Monitor. Installation and training The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business size standard is 500 employees Potential contractors must provide: 1. Company contact information. at a minimum shall include company name company physical and mailing addresses, company point of contact with phone number, fax number and email address. 2. Company DUN number and Cage Code; 3. Socioeconomic size status under the aforementioned NAICS/Size Standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran owned-small business, HUBzone small business, small disadvantaged business, woman-owned small business 8(a) small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representations and certifications are current); 4. GSA Schedule or other Federal Contract Vehicles under which this technology may be acquired; and 5. Capability statement identifying core competencies relate to this requirement, a detailed description of recent prior experience manufacturing or otherwise integrating same or very similar technologies to include client name and current contact information sufficient for the Government to verify the work performed, and technical specification, descriptive material, literature, brochures and other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or email to the point of contact listed below on or before May 31, 2011 by 1:00 pm CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1087217. This notice does not obligate the Government to award a contact or otherwise pay for the information provided in response. The Government reserve the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, Confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in a resultant solicitation that may result from market survey. If no responses are received to this announcement, this announcement will serve as notice of intent to award as a sole source contract to GE Healthcare of Piscataway, NJ. For information regarding this notice Contact, Marcia Park 870/543-7495, FAX 870/543-7990; or email to marcia.park@fda.hhs.gov.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1087217/listing.html)
 
Place of Performance
Address: Food and Drug Administration, White Oak Campus, 10902 New Hampshire Avenue, Silver, Maryland, 20993, United States
Zip Code: 20993
 
Record
SN02454636-W 20110525/110523234511-15c7f40359098f835146a5c10176c4d8 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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