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 325414-Biological Product (except
Diagnostic) Manufacturing with size standard 1250 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) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers.
The Repurposing Screening Group in the Therapeutics for Rare and Neglected Diseases (TRND) section at NCATS collaborates with leading investigators at NIH, universities and other nonprofit research institutions, and private-sector companies. TRND objectives include (1) identification of drug targets or disease phenotypes for assay development, (2) assay development and optimization for high-throughput screening, (3) drug repurposing screening to identify active compounds that reduce disease phenotypes, (4) confirmation of compound activity by using in vitro assays and animal models, and (5) advancement of the newly identified compounds to clinical trials for the treatment of rare and neglected diseases.
The TRND-D3-Newman project is part of the drug development and assay development portion of the program and requires cell lines for assay development to support medicinal chemistry. This project aims to develop a dopamine D3 receptor (DRD3) antagonist for treatment of substance use disorder (SUD). In order to fulfill this goal, the project group is performing medicinal chemistry to optimize DRD3 antagonists. In order to properly compare potencies and efficacies of each compound in the DRD3 cell line with the DRD2 and DRD4 cell lines, we need these cells and assays to be in the same format. Therefore, the reagents need to be compatible in form, fit and function to the previous results for purposes of maintaining continuity of research.
Purpose and Objectives
The purpose of this potential acquisition is to obtain cell lines, reagents and kits as identified herein that is manufactured by Eurofins DiscoverX Corporation, located at 42501 Albrae Street, Fremont,CA 94538. The cell lines are needed to continue studies of physiological receptors as part of TRND-D3-Newman HEAL initiative project.
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 the subject vendor deemed essential in meeting the government's needs.
Specifically, the following are considered essential characteristics of this potential requirement, or its equal:
• Cell lines: stable clonal cell lines that expedite drug discovery and development by providing robust response to over 90% of all known G-protein coupled receptor (GPCRs), with accurate pharmacology. This assay measures an essential pathway in GPCR activation, i.e. β-arrestin recruitment to activated GPCRs, enabling scientists to screen for and profile functional agonists and inhibitors of GPCRs.
• Cell lines: engineered to co-express the PK tagged GPCR and the Enzyme Acceptor (EA) tagged β-Arrestin. Activation of the GPCR-PK induces β-Arrestin-EA recruitment, forcing complementation of the two β-galactosidase enzyme fragments (EA and PK). The resulting functional enzyme hydrolyzes substrate to generate a chemiluminescent signal.
• Detection kit is to be used with PathHunter Cell Lines or cell lines made with ProLabel/ProLink expression or cloning vectors. The kit is easy-to-use and has been successfully run in both 96-well and 384-well microplate format. The resulting signal is chemiluminescent and is read with any standard plate reader. PathHunter products utilize the Enzyme Fragment Complementation (EFC) technology for studying protein protein interactions, protein translocation, receptor trafficking, and receptor internalization, all of which involve the complementation of two beta-galactosidase fragments.
• Cell plating reagent: designed to produce the highest possible assay performance. Each cell plating reagent was developed to maintain high cell viability and maximize ligand responsiveness for the duration of the cell-based assay while minimizing high basal activity by eliminating additional hormones and growth components that could impact the assay.
Products offered must be essentially equal to the supply described in this solicitation, which specifically includes the following manufacturer description, part code, and quantity:
PathHunter® CHO-K1 DRD2L (Long Isoform) ßArrestin Cell Line; 93-0579C2; 1 ea
PathHunter® CHO-K1 DRD2S (Short Isoform) ßArrestin Cell Line; 93-0351C2; 1 ea
PathHunter® CHO-K1 DRD4 ß-Arrestin Cell Line; 93-0690C2; 1 ea
PathHunter® Detection Kit; 93-0001L; 1 ea
AssayCompleteTM Cell Plating 2 Reagent; 93-0563R2A; 20 ea
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 applicable. A fixed-price type of Purchase Order contract is anticipated to be awarded on or around September 1, 2019. 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).