Light Scatter Detector

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 light scatter detector. 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. Part I: General Information Introduction In the United States, the FDA/CBER regulates licensing of polysaccharide (PS) and polysaccharide-conjugate vaccines for clinical use against Haemophilus influenza b, Vibrio cholera and streptococcal and meningococcal diseases. The LBP (Laboratory of Bacterial Polysaccharides) studies various aspects of PS (polysaccharide) and PS conjugate vaccines. MALLS (Multiple Angle Laser Light Scattering) is part of the routine characterization of intermediates in the manufacturing process of these PS and PS-conjugate vaccines. CBER is committed to improving FDA's capabilities in characterizing PS conjugate vaccines. The structural biology group studies structure-function relationships in PS and PS conjugates. The group uses Light Scattering as a tool to characterize the size and shape PSs and their protein conjugates at the molecular level. This information is related to the immunogenicity of these molecules, which in turn provides valuable insights into how PSs interact with antibodies and proteins. Background Light scattering is used to delineate the overall size and shape of molecules including PS and PS-protein conjugates. These characteristics have important consequences for efficacy as vaccines. The Structural Biology group currently has a Size-exclusion chromatography 18-Angle Laser Light Scattering (SEC-MALLS) unit. This unit was purchased in 2008 and is now severely outdated and as such, the manufacturer, Wyatt, no longer supports this instrument. The current instrument has a refractive index detector and also uses size-exclusion chromatography to separate molecules with vastly different sizes, which aids in their analysis. The group has used the existing SEC-MALLS unit to characterize the size and radius of gyration of polysaccharides, however, the current outdated instrument cannot be used to analyze PSs that are smaller than ~10,000 in molecular mass. The state-of-the-art version of the SEC-MALLS instrument can be used to study molecules as small as 200 in molecular mass. This version also has higher sensitivity. Dynamic light scattering (DLS) is another way to use light scattering to obtain data on large molecules. In this case, the hydrodynamic radius can also be obtained. DLS can be used to characterize molecular conformations, liposomes, and aggregates. Together DLS and SEC-MALLS provide a complete picture of the size and shape of the PS or PS-protein conjugate under study. Finally, the determination of macromolecule size and conformation can be aided by viscometry. The new instrument will provide improved sensitivity, increased molecular mass range and the ability to analyze large particles. This will aid in characterizing PS and PS-conjugate vaccines. Scope An updated light scattering instrument incorporating SEC-MALLS and DLS run using a single computer so that all data can be integrated and compiled. One year warranty and on-site service are also requested. This Sources Sought is for a Brand Name or Equal solution. Proposed equal needs to meet all the Requirements listed below and the intended use of the instrument to be deemed technically acceptable. Part II: Work Requirements Technical Requirements The new light scattering instrument shall: Be made of all new parts; Contain an 18-angle multiple angle laser light scattering detector/analyzer for static light scattering; Be capable of integrated size-exclusion chromatography; Include a refractive index detector; Be capable of determining the size and shapes of molecules in the range of 200 Dalton – 109 Dalton; Be capable of measuring DLS and SLS on a sample that has been subjected to SEC under control of the software; Include software for acquisition and analysis of SLS and DLS data; Include a viscometer; Include a flow-cell cleaning kit; Include hands on training for two lab members; Include one additional flow-cell; Include one year of technical support; Include on-site installation. Installation, training and additional system requirements The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. FOB Point destination to include inside delivery, installation, and clean-up of area after installation. The system shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, software, and that otherwise required to meet these specifications, the FDA’s stated need and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument shall not be accepted until those performance specifications have been met. The contractor shall provide all labor, travel, and tools to install the equipment at the address provided herein, to include shipping. The contractor shall provide guidance on pre-installation site requirements. The contractor shall demonstrate upon installation that the item meets all performance specifications. The instrument shall not be accepted until those performance specifications have been met. Equipment familiarization training for up to 2 people shall be provided at the installation site. The familiarization shall include but not be limited to routine maintenance, method setup, and sample analysis. The Government anticipates offering a trade-in of the existing SEC-MALLS instrument as a trade-in on the purchase of the new equipment: • Manufacturer: Wyatt Technology • Instrument: Multiple Angle Laser Light Scattering • Model: DAWN Helios II and Refractive Index Detector • Serial Number 236-H2HC and 821-REX Records and Reports The Contractor shall, commensurate with the completion of installation of new equipment provide the end-user of the equipment with a copy of installation report identifying the equipment name, manufacturer, model number, and serial number of the equipment being installed and updated software versions. In addition, vendor must provide a report of installation and operation verifying functionality of instrument for intended use. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery, installation and staff familiarization training shall occur within the contractor’s normal manufacturing lead times for these items but shall be no more than 150 calendars days from date of award. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave, Silver Spring MD, 20993. Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum brand name or equal technical requirements. 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, Unique Entity ID (SAM) 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. Past performance information within the last three years for the manufacture and/or sale 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 Unique Entity ID (SAM) number and size status) if not the respondent. Estimated Trade-in credit for the existing instrument. 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. If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on. 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; Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed; 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 by email to the point of contact listed below on or before July 5, 2022 by 13:00 hours (Central Time in Jefferson, Arkansas) to [email protected]. Reference CBER-2022-113787. 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 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).