SOURCES SOUGHT
66 -- Bioreactor
- Notice Date
- 8/23/2016
- 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 - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1166861
- Archive Date
- 9/13/2016
- 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
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for a laboratory bioreactor/cell culture bioreactor (fermentor) system. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. The Facility for Biotechnology Resources (FBR) within CBER is planning for a project on protein expression and characterization. The project will assist scientists to produce sufficient recombinant proteins for various studies. To achieve this, eukaryotic or prokaryotic cells harboring the desired gene(s) will be cultured in large volume of medium under a controlled environment in order to obtain sufficient number of cells for extracting expressed proteins. A bioprocessor (or fermentor) is thus needed to achieve automatic and reproducible operation. Scientists at CBER and Center for Drug Evaluation and Research (CDER) conduct cutting-edge biological research and review products related to pathogen identification, disease mechanisms, vaccine development (e.g., influenza and other viruses), or protocols involving cellular, tissue and gene therapies, etc. FBR is a core facility for both CBER and CDER. Often their studies require the analysis and characterization of proteins, either naturally expressed or from cultured cells engineered with recombinant DNA. One of the limiting factors in obtaining sufficient amount of a protein for analysis is the number of available cells for protein extraction. Most traditional small-scale culture in the lab uses petri dishes or bottle flasks (10-75 ml) to grow eukaryotic cells and Erlenmeyer flasks (1-2 liter) to grow prokaryotic cells. In order to achieve the desired number of cells, a general practice is to use multiple containers for the same culture. Such a practice requires large number of flasks or petri dishes and a lot of incubator space. Not only is the practice laborious because the need for repetitive distribution of medium and seeding of the culture, it also doesn't guarantee consistent cell growth and protein expression in different containers. A bioprocessor or fermentor could use various sizes of containers for cell culturing (0.3-5 liter, and up to 30 liter for laboratory scale experiments), depending on the cell number needed. It allows cells to grow under strictly controlled conditions (e.g., stirring rate, temperature, pH, dissolved oxygen, etc.) by the use of monitoring probes. Using a fermentor, it is easy to obtain large number of cells and also easier to control consistent and reproducible protein expression. For this reason and for the protein expression service we provide, a fermentor (or bioprocessor) system needs to be purchased. FBR provides high quality and high quantity proteins using recombinant expression systems for biologics, vaccines, monoclonal antibodies, protein structures, and various diseases research such as influenza, Ebola, Zika virus and cancers. For these purposes, the fermenter is an essential instrument for recombinant cell culture. The System shall be capable of universal control for mammalian, stem cell, insect, bacteria, plant, and algae cultures. The system is suitable for use in all the lab using batch, fed-batch, perfusion, and continuous processes for the expression of various biologics, vaccine, and monoclonal antibody. The instrument shall allow for simple research equipment for the production of recombinant products or a one-time single use Good Manufacturing Practice (GMP) production of clinical products. Performance requirements General specifications: The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. Minimum specifications 1. A bench-top fermentor (bioprocessor) system that has a small footprint, in the range of 1.5'x1.5'x2.WxDxH) due to bench space availability. Slightly smaller or larger bioprocessors will also be considered acceptable but none larger than 1.5'x1.5'x2.5" is accepted. The bioprocessor system shall use 120V electric receptacle for operation and touch-screen monitor for parameters entry. 2. The system shall accept interchangeable, autoclavable stainless vessels of 0.25-10 liters (working volume), with the option of using single-use vessels available from the same vendor. 3. The vessels take "push connect" connector for accepting inlet gas tubes for air, oxygen, or CO2 at 10 psi. This will prevent the need for tools and is leak proof. 4. The agitation (stirring) uses interchangeable high power "direct" drive (at 25-1200 rpm), or optional magnetic drive (from 25-500 rpm) assemblies. Both drives are capable of clockwise and counterclockwise rotation. Variable speeds are neeed due to the many applications reuire different RPM of stirring, e.g. mammalian cells is easily damaged with higher rpm, but fast growing cells (such as E. coli) need fast rpm for sufficient oxygen supply. 5. The system is equipped with sensors for pH (2-12), dissolved oxygen (0-200%), Redox (reduction-oxidation potential, -2000mV to +2000 mV), and CO2 (0-100%). It also uses built-in optical pH sensing technology for use with single-use vessels. 6. The system is controlled using software program(s) for automatic gas mixing algorithms and displaying up to 12 process values in a single view. It has a built-in elapsed fermentation timer for batch management. 7. The system controls simultaneously and automatically various factors such as temperature, pH, dissolved oxygen, RPM, air pressure, carbon dioxide, redox, and etc. 8. The system comes with a circulating chiller for efficient control of fermentor temperature (5oC to 40oC) which has a reservoir of >7.0 liters, and an output of >3.3 gpm (gallon per minute). Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of one (1) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 90 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave, Silver Spring, MD 20993. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/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. • Information on available service/maintenance plans. • Three (3) years of past performance information for the manufacture and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before August 29, 2016 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1166861. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 FedBizOpps. 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/1166861/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04236129-W 20160825/160823234630-a2a89990fbf211037cc708817d0acc7e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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