This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government’s potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 334516 - Analytical Laboratory Instrument Manufacturing with size standard 1000 employees. BACKGROUND The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Center for Advancing Translational Sciences (NCATS) is a translational science center whose mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Although antibody-drug conjugates (ADCs) have been widely used as anti-cancer drugs, there is no high-throughput ADC synthesis, characterization, and evaluation platform in which novel ADCs can be assembled and evaluated in a timely and cost efficient and effective manner to facilitate exploration of their application in novel indications in both oncology and non-oncology fields. Uncontrolled aggregation of ADCs can lead to a loss of their biological activities. Thus, monitoring stability of ADC in a high-throughput manner is essential. To date, Dynamic Light Scattering (DLS) has been one of the most effective techniques for submicron size analysis of proteins (such as antibodies) and their aggregates. High-throughput dynamic light scattering (DLS) with automated well-plate sampling with software enables the rapid and reliable characterization of ADCs. This potential requirement will provide dynamic light scattering (DLS) and static light scattering (SLS) measurements simultaneously, with as little as 4 µL of sample in a 1536-well plate and as much as 150 µL in a 96-well plate. This technique is quite new to the field and will expand the current capabilities in size analysis of submicron particles (such as antibodies and ADCs) at NCATS. Purpose and Objectives The purpose of this potential acquisition is to obtain one (1) Dynamic and Static Light Scattering High-Throughput unit on a Brand-Name-or-Equal basis to the DynaPro Plate Reader III as described and identified herein manufactured by Wyatt Technology Corporation, located at 6330 Hollister Ave., Goleta, CA 93117-3115, United States. The DynaPro Plate Reader III will provide NCATS scientists the ability to perform the measurements expected with acceptable accuracy, precision and repeatability. The DynaPro Plate Reader III is designed for use with a wide range of 96-, 384- and 1536-well industry-standard, disposable plates, and is a member of the fourth generation of dynamic light scattering (DLS) plate readers developed by this vendor. The instrument uniquely combines advanced technical features meeting current NCATS data acquisition and analysis software needs. Project Requirements Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the essential government features specified herein. Products offered must include those salient physical, functional, or other characteristics of the items identified in this notice that are manufactured by Wyatt Technology Corporation and deemed essential in meeting the government’s needs. Specifically, the following are considered essential characteristics of this potential requirement, or its equal: 1) The DLS instrument must perform measurements in situ in standard, commonly available and inexpensive 96-, 384- and 1536-well plates. It must be capable of completing a measurement of all wells in a 384-well plate in less than 90 minutes with acceptable accuracy and precision. 2) The measurements of multiple wells in the plate, and up to all the wells in a plate, must be performed in a fully automated manner after loading the plate into the instrument. 3) The measurements must take place directly in the well plate with no further liquid handling besides loading the samples into the plate. In particular, the sample should not be extracted from the plate for measurement. 4) The instrument must provide dynamic light scattering (DLS) and static light scattering (SLS) measurements simultaneously. 5) The range of measurement of hydrodynamic radius by DLS must cover 0.2 – 1000 nm. 6) The range of measurement of molar mass by SLS must cover 1000 – 1,000,000 g/mol. 7) The sensitivity of the DLS measurement must support quantifying the hydrodynamic radius of a purified solution of lysozyme at concentrations down to 0.125 mg/mL, with an accuracy of 5% and precision of 2%. 8) The sensitivity of the SLS measurement must support quantifying the molar mass of a purified solution of bovine serum albumin at concentrations down to 1 mg/mL, with an accuracy of 5% and precision of 2%. 9) The instrument must be capable of measuring as little as 4 µL of sample is a 1536-wellplate and as much as 150 µL in a 96-well plate utilizing an optical system with a 40 µm beam waist. 10) The instrument must provide temperature control from at least 4°C to 85°C with well-to-well uniformity of better than 1% utilizing Peltier elements with extensive thermal management. 11) The instrument must provide a means of imaging each well in order assess adverse phenomena such as precipitation, bubble formation or high turbidity utilizing a 3Mpixel onboard camera which can be programmed to acquire a photograph of the bottom of the well with each DLS measurement. 12) The instrument must utilize a near-infrared laser with wavelength longer than 820 nm in order to avoid exciting fluorescence which can overwhelm the DLS detector utilizing a laser with wavelength of 830 nm. 13) Validated through citation in peer-reviewed publications. 14) The instrument must have an onboard computer with a touch screen display to allow one to visualize rapidly any of the detector outputs including all count rate, autocorrelation function, etc. as well as critical status indicators such as temperature or well position allowing confirmation the system is operating properly and to diagnose problems. 15) The instrument must be capable of user-installed upgrades with new firmware releases. 16) The instrument must allow the user to reduce its laser intensity by 1% - 90%, either from the front panel display or from the control software. It must also be capable further attenuating the light intensity reaching the detector, automatically, by at least four orders of magnitude. These capabilities eliminate detector saturation due to very high concentrations of very large macromolecules or nanoparticles and protect the detector from exposure to damaging light levels. 17) Onsite training, installation and warranty in accordance with standard manufacturer commercial item warranty practice. Products offered must be essentially equal to the supply described in this solicitation, which specifically includes the following manufacturer part number, part name and quantity: WPR3; DynaPro Plate Reader III; 1 CK3000; DYNAMICS® 7 Software; 1 Y-TECHSUPP; Technical Support; 1 Y-LSUDA; 2-day Training Dyna-LSU; 1 Y-INSTALL1; 1-Day Installation; 1 Contractors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features of this potential requirement. Specifically, Offerors to this Small Business Sources Sought notice shall document evidence of being able to provide the subject supply that will allow for the essential features described herein to be accomplished. Delivery/Warranty Offerors must indicate an estimated delivery time in full after receipt of an order and any training or warranty or software licenses applicable, and/or if extended years of service coverage are applicable in accordance with manufacturer’s standard commercial item practice. A fixed-price purchase order type of contract is anticipated. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. CAPABILITY STATEMENTS/INFORMATION SOUGHT Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. Respondents must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order. Respondents that believe that they are manufacturers or authorized re-sellers of the equipment specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; (d) quantity; (e) estimated price or cost; (f) shipping, handling, and/or installation charges; and delivery date after receipt of order. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be in outline format that addresses each of the elements of this requirement. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Respondents must reference the subject announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at
[email protected], and be received prior to the closing date specified in this announcement. CONCLUDING STATEMENTS 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).