Manufacture of SARS-CoV-2 Human Challenge Material

Introduction/Synopsis This is a Small Business Sources Sought 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. Background The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. Purpose and Objectives NIAID awarded a one-year contract to support manufacture of SARS-CoV-2 Human Challenge material (HCM) to support Controlled Human Infection Model (CHIM) clinical challenge studies. The SARS-CoV-2 HCM will be used to develop and approve therapeutic and vaccine candidates for COVID-19. The development and use of a CHIM requires the manufacture of the BSL-3 SARS-CoV-2 at sufficient quality to be administered to humans, test the material in humans to find optimal dose and route, and then use this material to identify vaccines and therapeutics that mitigate SARS-CoV-2 infection and disease. Consequently, there is an urgent need to manufacture SARS-CoV-2 Human Challenge Material (HCM) that will be used in CHIM studies. A single lot of SARS-CoV-2 Human Challenge Material was manufactured in March 2021. However, in order to use this material in a CHIM the following activities must also be performed: release testing which requires additional assay development, stability testing of Master Viral Seed for 3 years, stability testing of HCM for 3 years, and manufacture of retain material. All of these activities are integral to the release and use of the manufactured SARS-CoV-2. In addition, several SARS-CoV-2 Variants of Concern continue to arise that require manufacture and clinical testing of additional strains of Human Challenge Material. Based on past experience, a new method is needed for development and manufacture of different strains of SARS-CoV-2. Consequently, there is a continued need to (1) develop a manufacturing method that minimizes mutant variants produced during the manufacturing process and (2) manufacture additional variant of concern strains of SARS-CoV-2. The Contract included the following: Base - Development of aSARS-CoV-2 strain as Human Challenge Material Option 1 - Additional Assay Development Option 2 - MVS Stability Option 3 - HCM Stability Option 4 - Retain Material Option 5 - Manufacture of Human Challenge Material Using a Molecular Clone Project requirements The project requirements include activities required to (1) release and demonstrate stability of the previously manufactured SARS-CoV-2 HCM and (2) develop a new method and manufacture variants of SARS-CoV-2. The requirements identified above can be broken down into the following activities and/or scope: Additional Assay Development - to complete assays required for HCM release and stability MVS Stability - to support use of the HCM HCM Stability - to demonstrate stability of HCM prior to use in clinical studies Retain Material - to support assays (reference standard) and support further characterization of the HCM Manufacture of Human Challenge Material Using a Molecular Clone - to develop methods that minimize culture induced mutations in the HCM and manufacture SARS-CoV-2 Variants of Concern Anticipated period of performance The SARS-CoV-2 Human Challenge Material requires stability studies to ensure the material retains appropriate infectious titers throughout the duration of clinical trials. Based on current estimates for clinical requirements a period of performance of 3 years is required. Note that the period of performance will begin approximately August 2021. Capability Statement / Information Sought Capability Statements should clearly convey information regarding the respondent's capabilities including: (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; and (4) institutional/corporate experience and management capability. Interested respondents must submit a capability statement describing their company's experience and ability to perform this effort that includes the following: A summary list of similar work previously performed; The professional qualifications and specific experience of staff who may be assigned to the requirement; Resumes for proposed key personnel, including the Principal Investigator, that reflect Education, and previous work relevant to the proposed requirement; Documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity; Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources; Demonstrated ability to carry out the work; How to Submit a Response / Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five (5) pages, excluding resumes. Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed? (2) demonstrated scientific and technical ability to carry out the work? (3) the professional qualifications and specific experience of staff who may be assigned to the requirement? (4) a general description of the facilities and other resources needed to perform the work. Tailored capability statements should also include an indication of current certified small business status? this indication should be clearly marked on the first page of your capability statement. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: DUNS. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Miranda Adams, Contracting Officer, at Miranda.adams@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify RFP-NIAID-DMID-75N93021R00013. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 5:00pm EST on April 21, 2021(04/21/2021). CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award an IDIQ contract or Task Order 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).