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FBO DAILY ISSUE OF AUGUST 06, 2009 FBO #2812
SOURCES SOUGHT

66 -- Bioreactor

Notice Date

8/4/2009
 

Notice Type

Sources Sought
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-09-1060836-SS
 

Point of Contact

Karen R. Petty, Phone: 301-827-8774
 

E-Mail Address

karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small business (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to obtain a Bioreactor. One of the important objectives of the critical path project on comparability of physicochemical parameters of manufactured proteins is to assess the post-translational modifications of the proteins produced out of mammalian cell culture. To this end we would like to employ a Bioreactor system in the laboratory that shall meet the following requirements in order to facilitate mammalian cell culture for laboratory scale protein production. (A). Shall have a built in computer or an on-board facility (built into the system rather than a separate computer) to control the various processes and input devices as well as a simultaneous display capability of the output parameters over time in a graphical format to understand the bio-reaction process. Shall be able to interface with multiple process controls, thus, it shall also be able to control and monitor multiple bioreactor vessels simultaneously, if and when deployed. (B). The system shall be able to display the data in real time in graphical format as well as be capable of exporting in other compatible formats for archiving and analyses. (C). The system shall be able to hold multiple programs (at least up to 10) and be capable of deploying them instantaneously without having to resort to program the system from a computer. (D). The system shall be able to control multiple processes up to at least 32. (E). The control system shall be customizable for process identification. Shall be able to accept analog inputs and outputs, for integration of multiple (up to 7 or 8) external devices. (F). Specifically shall have at least 3 pumps that can run at 2 to 100 rotations per minute and be capable of controlling additional number of pumps when needed. (G). The system shall be flexible to handle vessels of sizes 2.5 liter to 14 liter with ease. (H). The system shall be able to maintain temperature accurately at 5 C above the cooling water temperature. Further it shall be able to handle temperatures up to 80 C when needed at an accuracy of +/- 0.1 C. (I). The system shall be upward compatible for software upgrade and shall have the facility/ ports to accept improved software developed by the manufacturer as well as operating system developer in future. The following line item provides the above configuration: (1) M1287-2110 & M 1287-1010 Master Control Station, 120V. (J). The system shall have an overlay facility to minimize the frothing that commonly happens when high amount of excreted protein is produced by the cultured cells. In addition, the controller shall have at least 4 gas mixers (for air, oxygen, carbon dioxide and nitrogen), one thermal mass flow controller and facility to add more mass flow controllers if needed. These following items are required to achieve the above configuration: (2) M1287-2017 4 TMFC (0.1-5 slpm) (3) M1287-3550 Gas Overlay kit without TMFC (requires a rotameter) (4) M1287-3505 Gas Overlay Vessels Kit (5) M1287-3520 Rotameter (0-5 slpm) (11) M1287-9966 Barant variable speed pump 115V (13) M1287-5032 septum adapter kit (14) M1287-5002 (4manifold) Air Pre-filter assembly (15) M1287-9918 Pressure gage (0-30 psi) (K). The system shall be capable of accepting additional probes to the standard probes namely, secondary Dissolved Oxygen probe, a reduction-oxidation probe, a pH probe etc. The following items are required: (9) M1287-0401 5.0 L pH/DO Probe kit (10) M1287-0674 2.5 L/5.0 L pH/DO probe kit (L). Shall have a water jacketed vessels with stainless steel quick connections and shall not have glass projections for connecting hoses as they tend to break while handling. This facilitates controlling temperature in conjunction with a positive displacement chiller, without a need for cold water drain. (M). The impeller drive motor shall be magnetic and be capable of 25 to 500 rotations per minute to handle various types of impellers and also shall be controlled via the built in computer system. The following item is required to have the above configuration: (6) M1287-5069 5.0 L vessel assembly (N). The Bioreactor system shall be versatile in terms of handling various kinds of impellers required for different types of mammalian cells grown under specific conditions. Some of the commonly used impellers are: Spin filter impeller, pitched blade impeller, marine blade impeller. The following items are required: (7) M1287-5069 5.0 L Pitched blade Impeller kit Contractors shall satisfy the following requirements. Provide a detailed description of your company’s (including its teammates, if applicable) experience and demonstrated abilities to deliver each and every one (address each separately) of the following requirements: A fixed price contract is anticipated. This is a new requirement. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses to this notice shall be limited to [15] pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS _______ (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted shall be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA, may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is for Government market research only, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. RESPONSES DUE: All capability statements must be received by email to: karen.petty@fda.hhs.gov, on or before Monday, August 10, 2009 no later than 4:30pm, EST. Telephone calls will not be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1060836-SS/listing.html)
 

Place of Performance

Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, United States

Zip Code: 20903
 

Record

SN01899453-W 20090806/090805001241-d7f2131c20cd9086db1991eb2395778f (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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