Asexual Malaria Blood Culture Service for the National Center for Translational Sciences (NCATS)

SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00497 Title: Asexual Malaria Blood Culture Service for the National Center for Translational Sciences (NCATS) Classification Code: Q301 - MEDICAL- LABORATORY TESTING NAICS Code: 541380 - Testing Laboratories Dollars or Number of Employees: $22 million Description: The purpose of this requisition is NCATS needs Asexual Malaria Blood Culture Service 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, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it 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. The scope of this work is for a 12-month malaria culture service that will provide asexual blood stage cultures human blood and complete culture medium on a monthly basis. Malaria affects an estimated 250 million people worldwide, particularly in the tropical regions of Sub-Saharan Africa and approximately 650,000 patients die each year. Even while on current therapies, patients remain infectious for a period of time, allowing further mosquito-borne transmission to others. Control of parasite transmission is critical for elimination and eradication of malaria. Torin2 was identified in NCATS as a lead molecule in a new class of antimalarial drugs. As part of the lead optimization program, the Malaria project team has been using a malaria asexual parasite viability assay to evaluate the activities of analogs aiming at advancing a drug candidate through pre-clinical development and early clinical development. The team routinely performs the assay to test the activity of the analogs in killing the plasmodium faciparum parasites that have infected the blood. Purpose and Objectives: The objective of this acquisition is to acquire the plasmodium faciparum parasites allowing the Malaria project team to perform monthly parasite assay. Monthly asexual stage parasites for use in viability assays: 1. Plasmodium falciparum asexual parasites (30 mL), with ring stages >90%. 2. Complete medium (100mL) for asexual parasites. 3. 50% Blood (1-5 mL). Project requirements: Monthly, 30 ml asexual parasites at 1% parasitemia and 4% hematocrit are needed to this project. Ring stages must be >90%. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, and 5% O2) all the time during the shipment. Additionally, 100 ml complete medium and 1-5 ml human blood are needed for the assay. The cultures will be used in house for viability assays for 72 hour drug sensitivity tests. TDB has developed assay for the drug viability test. The viability assay prefer to >90% ring stage in asexual parasite culture for a successful assay. Additional 1-5 ml of 50% blood and 100 ml complete medium are required for assay dilution. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. If assay fail because of lower than 90% ring stage provided. Sanaria will provide another 30 ml asexual culture in the following week or two until the drug efficacy assays work. Any additional asexual culture will be provided at no additional cost. If the drug efficacy assays fail because of TDB biology related issues, Sanaria will not provide additional culture. TDB has an option to order 5 additional supply of 30ml of the asexual cultures, blood and medium due to project needs. The contract will be 6 month. TDB will order asexual parasites monthly. TDB may terminate the contract at any time. All work must be conducted with strict compliance to vendor Standard Operating Procedures (SOP), with all excursions from these SOP immediately reported to TDB and comprehensively noted in the final report. Anticipated period of performance: Anticipated to 12 months from ARO Other important considerations: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the work mentioned above. Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the services specified in this notice. Also, information must be provided in sufficient details of the respondents (a) staff expertise, including their availability, experience, formal and other training; (b) current in-house capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and other management capability; and (e) examples of prior completed Government contracts, references, and other related information. 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. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2 x 11 paper size, with 1 top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. 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. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Nick Niefeld, Contract Specialist at e-mail address contact@example.gov. The response must be received on or before July 21, 2023, at 9 am Eastern Time. - 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 presolicitation 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).