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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 R... 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 bioreactor system. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. 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. Statement of Work (SOW): Xuri cell expansion W25 Bioreactor system “brand name or equal”. Part I: General Information A. Introduction The mission of the Tumor Vaccines and Biotechnology Branch at the Division of Cellular and Gene Therapy, Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research at the FDA is to develop and promote technology for safer Vaccines to improve public health. The Branch needs to have assessed identity and characterization of gene and cell therapy products to perform critical path research for its mission to develop and promote technology to regulate vaccines. The branch has developed many molecular and cellular biological technologies to understand the tumor biology and regulation of receptors for the Th2 cytokines IL-4 and IL-13. We demonstrated that these receptors are overexpressed in a variety of human cancers at protein and mRNA levels. To understand the biological significance of IL-13 and IL-4 receptor overexpression on tumors, the branch has developed chimeric fusion immunotoxins consisting of IL-13 or IL-4 and truncated Pseudomonas exotoxin and adoptive T cell therapy products. The branch has also developed cellular and molecular biological assays to assess the identity, potency, safety and efficacy of these immunotoxins and other related biological biomarkers. Recently, we have developed a chimeric antigen receptor viral vector to engineer T cell (CAR-T cells) expressing scFv anti IL-13Ra2, which will identify IL-13Ra2 expressing tumor cells in vivo and in vitro. These products are known to induce a cytokine storm in in vivo animal models and human patients undergoing CAR-T therapy. In addition, we have identified and characterized CAR-T cancer vaccines for their efficacy in vitro and now planning to study in pre-clinical mouse models of human cancers. These studies are the core of our Branch’s mission, which focus on studying the efficacy, stability and potency of these cancer vaccines and many other biological products. This is an urgent mission to have critical quality attributes of gene and cellular therapy products, we need to have a large number of CAR-T cells and hematopoietic stem cells and progenitor cells grown in a closed system such as Xuri cell expansion W25 Bioreactor system. The current cell expansion system is no longer functioning. Therefore, it is urgent and mission critical. A large number of CAR-T cells are needed to characterize CQAs in vitro and study safety and bio-distribution of CAR-T cells in vivo in mouse models of human cancers. The project aims to studying important issues of product manufacturing, which should be flexible, scalable and reproducible ensuring GMP-compliant products and finally should be cost-effective. The research also focuses on comparative assessment of critical quality attributes (CQA) of human CAR-T cell products targeted to tumor antigens expressed on a variety of human cancers (phenotypic and functional assessment) produced by different platform technologies. In addition, the study aims on optimizing critical process parameters for the isolation, activation and transduction of T cells by lentiviral vectors for production of CAR-T cells. The manufacturing technologies may include closed system, conventional approach and bioreactor expansion of CAR-T cells. B. Background The Xuri Cell Expansion System W25 is a closely monitored and highly controlled system for growing large quantity of T- cells. The customized parameters such as the motion, speed, and angle of the rocking platform suit to grow different cell types and culture conditions while process parameters such as temperature, pH, gas transfer, and flow rates are monitored by a range of propriety optical sensors and controlled software. With media perfusion, cell expansions reaching > 10 × 106 cells/mL are possible in working volumes up to 25 L. More than six users in our branch will use this system for their mission related research. C. Scope As our project aims at CAR-T cell expansion in a choice of single-use, the cell bag platform of Xuri bioreactor allows with working volumes between 300 mL and 25 L. The T cell products can be manufactured from multilayer, laminated, clear USP class VI plastics using this system, which provides a functionally closed environment that minimizes the chance of contamination between different samples or with adventitious agents. The Xuri W25 system consists of cell expansion W25 CBCU with gas flow/mix controller, pH and dissolved oxygen (DO) sensors, expansions base unit, client computer with Unicorn software. The CBCU delivers gas of a defined composition to the culture and is used in conjunction with optical sensors fixed to the bioreactor for online control of culture pH and DO. The Xuri Cell Expansion W25 Pump delivers and removes media to and from the bioreactor. Flow rates can be adjusted for a range of processes including acid/base additions, delivering fresh medium for perfusion cultures, and harvesting. In TVBB/DCGT, we have been working on studying such attributes of cell and gene therapy products and shown interest in developing advance manufacturing technologies using such system to test the critical quality attributes such as the viability, potency, stability and efficacy. Thus, it will also enhance our review and regulatory abilities to review cancer vaccines or stem cell related regulatory files. Part II: Work Requirements: Brand name or equal The Xuri Cell Expansion System W25 is useful for a variety of cell culture applications such as rapid production of clinical grade T-lymphocytes, perfusion culture of T-lymphocytes, perfusion culture of human natural killer cells. It consists of cell expansion W25 CBCU full, cell expansion system W25, W25 pump, Unicorn 7 workstation pur-BP-exp, computer, trays, lids, bags. The system has following main technical features: The Xuri Cell Expansion System W25 consists of a base unit, an environmental control unit (CBCU), and a pump Operations, control, and monitoring of the process are managed by UNICORN software installed on a client computer. The base unit is used in combination with a tray and a disposable Cellbag Bioreactor and has multiple functions including heating and culture mixing plus weight and temperature measurement. The CBCU delivers gas of a defined composition to the culture and is used in conjunction with optical sensors fixed to the bioreactor for online control of culture pH and DO. The Xuri Cell Expansion W25 Pump delivers and removes media to and from the bioreactor. Flow rates can be adjusted for a range of processes including acid/base additions, delivering fresh medium for perfusion cultures, and harvesting. Base Unit Proprietary Rocker, Temperature sensor, scale, embedded controller and dual hard drive CBCU Gas flow control range 50 to 1000 mL/min Total gas flow accuracy (reference flow–set-point) ± (10 + 3% of read value) mL/min Fast-fill flow ~ 3 L/min CO2 control range 0% to 15% CO2 CO2 measurement accuracy at 5% CO2 ± 0.5% CO2 when mixed only with air/N2 CO2 control accuracy (versus set-point) ± 0.4% CO2 O2 control range 0% to 50% O2 when mixed with N2, 21% to 50% O2 when mixed with air O2 measurement accuracy ± (0.6% + 1% of read value) % O2 within 0% to 50% O2 when mixed only with air/N2 O2 control accuracy (versus set-point) ± 0.6% O2 pH measurement range pH 4.5 to 8.5 pH control range pH 6.0 to 8.0 pH measurement accuracy ± 0.05 pH within ± 0.25 pH from offset calibration pH ± 0.1 pH within 0.25 to 0.5 pH from offset calibration pH control accuracy (versus set-point) ± 0.05 pH DO measurement range 0% to 250% air saturation DO measurement accuracy ± 5% air saturation (excl. atmospheric pressure variations) DO control range 0% to 100% air saturation Xuri Cell Expansion W25 Pump Pump flow rate range 0.1 to 144 L/d (0.07 to 100 mL/min) Pump flow accuracy ± (0.1 + 5% of read value) mL/min after calibration Accumulated pumped volume accuracy ± 10% of measured volume Supported tubing dimensions i.d. 0.5 to 4.8 mm (1/50” to 3/16“) wall thickness: 1.6 mm (1/16”) The System must offer flexibility in scaling up or down in T cell manufacturing using specified materials with different temperature requirements simultaneously. Accessories: no extra accessories are needed. B. Deliverables Contractor shall deliver the system and set up in White Oak complex, Building 52/Room 3134 Part III: Supporting Information Security Contractor shall pass through White Oak Campus (Silver Spring) security for access to White Oak Campus and deliver to Building 52, loading dock, Silver Spring, MD. Place of Performance Deliver to: Name to be provided at time of award. Bldg. 52/72. Room 3134, White Oak complex, 10703 New Hampshire Avenue, Silver Spring, MD 20993 Period of Performance Delivery shall occur 90-120 days from date of award. Special Considerations The reliability and integrity of the system is important. If the system should fail, we could lose precious biological products that are extremely expensive, precious and time-consuming to reproduce. During the warranty period the vendor should send their qualified service engineers within 24-36 hours for repair of the equipment to save critical expensive, time-consuming experiments. The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. 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. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for the system. Installation and training will be performed by the manufacturer. This shall include training during the installation visit (to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements) and a second visit to help optimize sample visualization. The second visit shall last up to 3 days and include training for no more than 2 specified users. Sample types: this microscope shall be able to accurately image ex vivo live isolated cerebral capillaries from mice, rats, non-human primates, and human brain samples (generally 4-10 um in diameter and 100-300um in length); fixed imaging brain sections on slides from mice, rats, and non-human primates (anywhere from 10 to 1000 um in thickness); and live and fixed cells in culture dishes or mounted on slides (10-500 um thickness). 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. 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 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. For “equal” products, including “equal” products of the brand name manufacturer shall meet the salient physical, functional, or performance characteristic specified in this notice; clearly identify the item by brand name, if any; and make or model number. “Equal” responses shall include a narrative describing how the offer meets each salient characteristic as well as an explanation of how each salient characteristic is fully met and meet the research needs of CBER. The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA’s stated need. Information on available service/maintenance plans. Provide recent (within the last three (3) years) and relevant 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. Respondents who do not provide a valid email address for the POC may be evaluated negatively. Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable for each item to this potential 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 required. 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 by email to nick.sartain@fda.hhs.gov on or before August 26, 2020 by 13:00 hours (Central Time in Jefferson, Arkansas). Reference FDA1228379. 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 beta.SAM.gov. 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).