SOURCES SOUGHT
66 -- Parallel Bioreactor system
- Notice Date
- 3/21/2011
- 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
- 1085905
- Archive Date
- 4/14/2011
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS FOR MARKET RESEARCH PURPOSES ONLY, NOT A REQUEST FOR PROPOSAL OR SOLICITATION. The Food and Drug Administration, Jefferson Laboratories, in Jefferson, Arkansas, is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, and 8(a) certified companies. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The government is seeking capability statements from small business manufacturing companies that can provide a parallel bioreactor system for mammalian cell culture with at least (8) vessels. The vessels are glass and have metal housings and head plates and the unit must be autoclavable (at 121°C) to provide a sterile environment for cell growth. The system must have physical and software capabilities to utilize existing equipment and potentially new acquisitions. The Division of Product Quality Research currently has basic bioreactor capabilities and needs to expand capacity to support the characterization of the Monoclonal Antibody manufacturing process to understand critical variables and utilize process analytical techniques (PAT) and Quality by Design (QbD) techniques. The instrument system shall meet the technical requirements described herein. • Parallel bioreactor system for mammalian cell culture with 8 vessels to study the effects of changes in the manufacturing process on product quality attributes. The vessels are glass and have metal housings and head plates and the unit must be autoclavable (at 121°C) to provide a sterile environment for cell growth. The division needs to expand its ability to characterize the monoclonal antibody production process to understand critical variables and utilize process analytical techniques (PAT) and Quality by Design (QbD) techniques. • Size: 400 mL-1200 mL vessels, but flexibility in the size of vessels utilized by the system up to 4L, without having to change modules or controllers, only by changing vessel assemblies. • Head plate: Metal with at least 6 threaded and capped 13.5pg (12mm) or 19mm ports (or combination of the two sizes) for Required sensors and piping, with 1 PG13.5 (12mm) Port available for the addition of 3rd party probe (furnished as a plug cap or septum) o Probes to be supplied and monitored: pH, dissolved Oxygen, and temperature. o Adequate Ports and Piping: Sampling, feeding, sparge, and exhaust o Multiports: At least 2 of the dedicated headplate ports will utilize at least 3 input and/our outputs on a single port. The multiports may be used for feeding pumps, sampling, gas addition/exhaust, or other purposes but must not interact with each individual activity of the components in the multiport. o Temperature Control: Automatic temperature control via heating and cooling, can be jacketed vessel, electric heating with cooling fingers, or equivalent. The source must supply an adequate Recirculating chiller (if necessary) to support their system to maintain precise temperature control. • Capable of independent vessel control of heating, cooling, agitation rate, substrate feed rates, and other probes. • Capable of physical and software integration of optional 3rd party probes and accessories (such as FT-NIR, Auto samplers, etc...). • Gas mixing off all 4 supply gasses (Nitrogen, Carbon Dioxide, Oxygen, and Compressed Air) to support 4 vessels, must be performed by a mass flow controller equipped electrothermal control. • At least (16) Peristaltic feeding pumps (2 per vessel) which can be individually adjusted for speed, run in reverse, run in "triggered" feed mode based on shifts in operating conditions, and programmed via algorithmic logic to make real time automated processing adjustments based on internal processing data, as well as external OPC connected real time at-line analytical data (i.e. nutrient analysis, cell count/viability, HPLC analysis, and others). Additionally, the control software needs to account for varying tube sizing for accurate delivery. The pumps must be capable of extremely low flow rates of 0.1mL/Hr, while maintaining accuracy. • Overhead drives (not magnetic driven stirrers) must be used to stir the vessel with a pitched blade impeller. • Individual support structures to prevent the reactors from falling over or sitting directly on the benchtop. • OPC connectivity, licenses, and installation for each of the 8 vessels, capable of monitoring critical processing parameters and creating a control feedback loop with the option of user defined algorithmic logic for automated processing decisions, from external analytical and sampling accessory values with accessibility from remote locations. • Run data exportation: The bioreactor software must be able to export run data to MS excel for end of run data manipulation, appropriate macros or excel add ins for charting and data organization must be provided. Time stamping must occur automatically, and storage of in-process data should only be limited by the hard drive of the space of the system computer (i.e. 5 days of data with an autoreset is unacceptable). All data should be easily exported for further processing and backup. 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 indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number and email address of point of contact. Capability statement must provide enough information to determine if the company can meet the requirement. At a minimum provide the following: Specifically address technical specs identified above to show the proposed instrument meets the requirements. Other descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Provide two contact names, email and phone for users of the proposed system that may be contacted by the government. Identify if the item is on the firm's GSA Schedule contract by schedule number and SINs that are applicable are also requested. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before March 30, 2011 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference 1085905. For information regarding this market survey, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. 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 any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1085905/listing.html)
- Place of Performance
- Address: U.S. FDA 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02405430-W 20110323/110321234334-630f78d23cc9293fd9fc61188cbc805f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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