Due: January 6, 2025
In accord with the Department of Defense (DoD) 2022 National Defense Strategy identifying Building Enduring Advantages, there is an effort to invest in manufacturing capabilities within the continental United States (CONUS) as part of efforts to bolster the Defense Industrial Base (DIB) and securing domestic supply chains. In recent years, there has been a shortage of much
needed blood storage bags, and this is acute within the DoD system where there is a requirement for singly wrapped blood bags for use in far forward situations.
DoD’s diverse warfighting capabilities means that Sailors, Marines, Soldiers, Airmen, Guardians and Joint Special Operations Service members operate in a vast array of challenging, remote, and austere environments. In forward positions there is a high probability of traumatic injury and wounds leading to blood loss. Hemorrhage is the leading cause of death in combat zone trauma. The gold standard for immediate treatment of hemorrhage is transfusion of whole blood however, the availability of whole blood and conventional blood products on forward missions is challenging. In recent years there have been supply chain disruptions across the continuum of military and civilian products. This includes components used in the manufacture of blood bags from the polymer components to the anticoagulant/preservative solutions within the bag. This has resulted in shortages of single blood storage kits most often used in austere environments especially for walking donors. According to the US Food and Drug Administration Center for Biologics Evaluation and Regulation for regulated products shortages website, the shortage of series of blood collection bag kits and products is described as ongoing. Shortages of ingredients, components and manufacturing supplies, and release timing issues are intermittent and unpredictable. Product may be placed on allocation as necessary to manage reduced or unavailable supply. This vital product is needed in steady supply to meet the needs of aiding wounded warriors within the golden hour, or sooner, out in the field at the point of injury with donated blood. Our approach is to stand up or bolster domestic production. The Government seeks Project Information Papers regarding the development of a prototype system detailing the following:
Production of a bag within the contiguous United States within 2 years of award that
meets the following existing specification:
Individually wrapped single aseptic collection bag
- Compliant with FDA (21 CFR 864.9100), ISO 10993 and 3826, USP and MIL 810H standards and guidance.
- Supports whole blood donor phlebotomy of 500mL (+/‐10%, 450‐550 mL) or 450 mL (+/‐10%, 405‐495 mL).
- Contains a solution of anticoagulant and preservatives meeting the USP standards that allows for storage of blood for at minimum 21 days up to 35 days.
- Foil wrapping that is easy to open requiring no tools and if practical, textured for better grip with brightly marked notches not only at the corners but also in the center of the packaging.
- The manufactured bags should have a shelf life of 18 ‐ 24 months at room temperature.
- Appropriate fatigue and distortion testing.
- Experience designing medical devices specifically blood products and adhering to verification and validation guidance.
- Within 2 years, capability to manufacture no less than 10,000 standard blood donor/storage bags per year and have a surge capability plan during times of increased demand for full single blood bag kits with compliant materials and processes.
Any established current Good Manufacturing Practice (cGMP) ready methods with fully
designed hardware and functional disposables.
- Manufacturers implementing GMP that require financial assistance to meet all requirements of the U.S. Food and Drug Administration (FDA) with clear standard operating procedures and compliance documentation (21 CFR 864.9100) shall
provide appropriate substantiating information, including a workflow for obtaining GMP certification.
Demonstrable redundancy in sourcing of raw materials from multiple vendors.
A notional rough order of magnitude estimate of proposed program cost inclusive of any cost share and other funding sources that the offeror has secured.
This opportunity requires membership in the MTEC Consortium. This Consortium releases numerous opportunities throughout the year, so even if this one may not be right for you, we strongly encourage you to join the consortium, so you are ready for the next opportunity.
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