JPEO-CBRND EB RAPID ACCESS TO PRODUCTS IN DEVELOPMENT (RAPID) RFI

Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, Enabling Biotechnologies (JPEO-CBRND-EB) Request for Information (RFI)

W911SR-26-RFI-RAPID

Description

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY –   This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future.  Solicitations are not available at this time.  Requests for a solicitation will not receive a response.  This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever.  All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government.  Not responding to this RFI does not preclude participation in any future RFP, if any is issued.  It is the responsibility of the potential offerors to monitor Sam.gov for additional information pertaining to this requirement.

The JPEO-CBRND-EB, develops, manufactures and delivers safe and effective Medical Countermeasures (MCMs) for preparedness, prevention, protection, response, and recovery from CBRN threats. Today’s chemical and biological threat landscape is diverse, dynamic, and regionally distinct. Agile and flexible defense systems are required to provide Combatant Commands (CCMDs) and other stakeholders throughout the Chemical and Biological Defense Program (CBDP) with actionable information regarding MCM availability at the speed of relevance.

The Rapid Access to Products in Development (RAPID) program is an integrated defense system composed of both physical MCM storage and fielding capabilities and a readily accessible information storage and sharing system (the RAPID Database). Collectively, these components of RAPID work synergistically to provide CBDP decision makers information for determining portfolio investment strategies and CCMDs with direct access to safe and effective prophylactics and therapeutics in development that can be advanced and fielded in response to credible intelligence or chemical/biological surprise.

To enable the storage of physical MCM doses and associated material in the RAPID program, JPEO-CBRND-EB is seeking the following information (including but not limited to):

STORAGE, INVENTORY MANAGEMENT, DISTRIBUTION, RETRIEVAL AND DISPOSAL CAPABILITIES 

1. Provide information on overall storage capabilities, ranges accessible and types of materials handled (e.g. drug substance, drug product, cell banks).
2. Provide compliance status with current Good Manufacturing Practices (cGMP) regulations, including qualification status of relevant equipment (e.g., storage chambers, etc.).
3. Provide information on the physical security measures in use to prevent unauthorized access to materials and data.
4. Provide information on control of your storage facility to include necessary environmental controls during the receipt and inspection process for: humidity, temperature, moisture, and air quality. Describe the continuous environmental monitoring systems used, alarm systems, excursion handling procedures and studies used to demonstrate and document temperature and humidity uniformity within the storage chambers. 
5. Provide information on your inventory management system. 
6. Describe material handling procedures for receiving, handling, storing, and retrieving materials to ensure proper identification and prevent mix-ups. Include information about the management of reference standards that are used in stability testing.
7. Provide information on your cold chain management system to include shipments to Continental United States (CONUS) locations at -80oC, 2-8oC and under controlled or ambient temperatures during shipping.  Also include capabilities to ship outside Continental United States (OCONUS) locations by expedited methods and maintain a temperatures ranging from -80oC, 2-8oC and under controlled or ambient temperatures during shipping. 
8. Provide information on your ability to dispose of product and materials by incineration, autoclaving, or chemical disruption in accordance with local, state, and federal guidelines. 

STABILITY TESTING OF VARIOUS CRITICAL MATERIALS, DRUG PRODUCT, AND DRUG SUBSTANCE LOTS

1. Provide information on your capability to perform stability testing on various cGMP drug products, cGMP drug substance lots, associated reference materials and other critical reagents in accordance with Good Laboratory Practice (GLP) guidelines.
2. Provide information on ability to draft and execute study protocols in accordance with ICH guidelines for all stability tests, and to provide comprehensive results and reports including testing failures and re-testing procedures. 
3. Describe if any of the storage capabilities described above are different during the performance of stability testing.

QUALITY ASSURANCE CAPABILITIES 

Provide information on your quality management system that is equivalent to ISO 9001:2015 standard and if aligned with MIL-STD-1916 where appropriate. 

Provide information on quality assurance practices. Examples include change control processes describing modifications to facilities, equipment, or procedures; documentation and investigation practices for deviation management; calibration and preventative maintenance programs; and audit trail documentation of activities. Describe how data integrity is maintained such as secure data storage and retrieval systems and mechanisms to ensure data accuracy, completeness and traceability. 

CONFIGURATION MANAGEMENT CAPABILITIES 

Provide information on your configuration management experience to include requirements management, data management, change management, records management, document control, library management. 

PROGRAM MANAGEMENT CAPABILITIES 

Provide information on your Program Management experience to include technical and administrative support, standard operating procedures, supply chain management, and risk management.  

The response date for this market research is October 31, 2025.  All responses to this RFI may be submitted via e-mail to David Bailey, Director – Data & Technology Integration for Readiness (DTIR), JPL Enabling Biotechnologies at david.e.bailey113.civ@army.mil, courtesy copy to Scott Hoffman, ACC-APG Contracting Officer, at scott.i.hoffman2.civ@army.mil.