Sources Sought Notice (SSN) Stability Testing Of rBV A/B And rF1V Critical Material Lots

W911QY-21-S-STAB Sources Sought Notice (SSN) Stability Testing Of rBV A/B And rF1V Critical Material Lots Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical and Biological Defense Medical is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below. Background: In order to maintain critical capability to respond to potential emergencies, the USG is seeking the capability to continue stability testing of rBV A/B and rF1V critical material lots and reagents in anticipation of ongoing and future activities. Testing of critical material includes the continued testing of several lots of cGMP drug product (DP), cGMP drug substance (DS), associated reference materials, and other critical reagents. The JPM CBRN Medical's rF1V vaccine is intended to protect adults from aerosolized pneumonic plague caused by inhalational exposure to Yersinia pestis. Vaccine potency (for stability) is tested using the validated relative potency assay. The JPM CBRN Medical's rBV A/B vaccine is intended to protect adults from fatal botulism caused by inhalational intoxication from exposure to Botulinum neurotoxin (BoNT)/A1 and BoNT/B1. Neutralizing antibody-combined (NAC) and vaccine potency (for stability) are tested using validated mouse bioassays. The vaccine programs are in advanced development, having completed safety and efficacy studies through a Phase 2 human clinical trial. Newly manufactured lots of rBV A/B and rF1V were completed in late 2020 and early 2021. The intent of the work described here is to continue stability testing for these newly manufactured lots, previously manufactured lots, and critical materials associated with these programs. Requirements: All facilities shall follow standard GLP for testing, re-testing, and reporting, as necessary Final documentation of Standard Operating Protocols (SOPs) shall be provided as supporting documentation. Testing results shall be reviewed and signed by testing facilities quality assurance units as necessary and provided to JPM CBRN Medical for review and approval prior to final payment. Biweekly meetings for status updates from subcontractors (JPM CBRN Medical to attend in listening mode) and Report, record of meeting agenda/minutes with subcontractor. Monthly progress, status, and management report of effort Data generated under this contract are considered Department of Defense Controlled Unclassified Information (CUI) and fall under ITAR 120.10 whose export is restricted by the Arms Export Control Act (Title 22, U.S.C. Sec 2778, et seq.) The Respondents shall provide the following in response to this this SSN: 1. Company Description Provide a company description, history and experience emphasizing capability to execute multiple stability timepoints for multiple products, in compliance with FDA guidelines, to include reporting, quality oversight, and subcontractor SOP's. Capability to manage multiple subcontractors capable of performing FDA compliant stability testing on multiple products and reagents. Demonstrated capability to execute multiple technical transfers of qualified assays and data in compliance with the FDA. Provide information related to the company's quality systems (e.g. ISO 13485 or FDA QSR) Do you anticipate any foreign nationals working on the project? CAGE and DUNS Business Size 2. System Description A description of proposed performance characteristics Ability to meet the performance objectives specified above Administration: The Government will retain comments and information received in response to this SSN. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 22 Mar 2021. Responses should be sent by e-mail to: scott.i.hoffman2.civ@mail.mil, with Subject Line of Responding Organization and SSN Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this SSN, posting will either be announced through beta.sam.gov.