Dried Plasma Product System – Seeking New Technologies and Development Partners

Purpose

MTEC, in support of the Naval Medical Research Command (NMRC) and Naval Advanced Medical Development (NAMD), is excited to post this Request for Project Information (RPI) focused on surveying the current state of engineering and medical prototypes, knowledge products, and manufacturing capacity related to the dried plasma products for use by warfighters.

This Request for Project Information (RPI) contains background material and guidance for the preparation of project information papers to MTEC. Project information papers will be reviewed by the Sponsor and used in a manner that shapes NAMD efforts in this technology space. The results of the project information paper submission will serve to assess the development landscape and potentially focus efforts that will follow.

As a note: This RPI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RPI. Responses to this notice are not offers and will not be accepted by the government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RPI. All information received in response to this RPI that is marked “Proprietary” will be handled accordingly.

Background

Due to the Navy and Marine Corps’ diverse warfighting capabilities, Sailors, Marines, and Joint Service members operate in a vast array of challenging, remote, and austere environments. 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. The quantities needed to resuscitate and transport injured warfighters back to medical facilities away from the field may not be available in addition to the demands of thermoregulation controls and energy requirements and the availability for accessory equipment required for conventional whole blood and frozen plasma stores. Dried plasma products present a potential solution to these logistical issues for meeting the needs of warfighters in the field. It is lightweight and thermostable across a spectrum of temperatures without requiring refrigeration or freezing. Dried plasma products have been repeatedly called for from role of care (ROC) level 1 up through ROC 4 personnel and further up the chain of command to the Secretary of Defense’s office. This vital blood product is needed to meet the goals of aiding wounded warriors within the golden hour or sooner out in the field at the point of injury. Dried plasma offers the opportunity to have a lightweight, room-temperature thermostable product in a ruggedized kit so that it can be stored in a medic’s pack, submarine, or in field/ship hospitals without requiring refrigeration or special handling.

Focus Area of Interest: Advancement of Dried Plasma Production System

The Government is interested in mature technologies, devices, and methods for the production of a dried plasma product suitable for universal blood types. This plasma product is to be used where fresh or frozen plasma is unavailable for the treatment of traumatic or mass casualty events occurring in military populations, often operating for extended periods of time in austere/extreme environments. Alternative technologies capable of filling the role of dried plasma during traumatic or mass casualty events may also be of interest. The Government invites Offerors with the following production capabilities to submit informational papers using the template included in Addendum 1 of this RPI. Should an Offeror be unable to meet all the desired capabilities, they should detail a plan to establish the remaining functions. Offerors should have:

• Established Good Manufacturing Practice (GMP) ready methods with fully designed hardware and functional disposables.
• Input plasma that meets all requirements of the U.S. Food and Drug Administration (FDA) (21 CFR 630.10 and 630.15; Part 640, Subpart G) with clear standard operating procedures and documentation as described in relevant transfusion-transmitted infections (RTTI; 21 CFR 610.40).
• Pathogen reduction capability using FDA approved methods. This would ideally be at the forefront of manufacturing whether on the preparation of the plasma pre- or postdrying.
• Clearly defined chemistry, manufacturing, and controls processes.
• Full characterization of analytes not limited to those described within the FDA guidance entitled, “Considerations for the Development of Dried Plasma Intended for Transfusion” (2019).
• A notional estimate of any cost share and other funding sources that the offeror has secured.

Interested Offerors should include information on their expertise in any or all the following technology areas as it relates to the dried plasma development and combat injuries involving the need for transfusion:

• Development of mature products at Technology Readiness Level (TRL) 6 or higher that require funds and guidance to navigate the U.S. regulatory landscape at the FDA as it relates to blood products.
• Ruggedization of the dried plasma kit to meet the needs of the military in austere environments.
• Manufacturing of dried plasma kits and or equipment (scale-up, initial production runs, etc.) that may include proprietary processes, programming, and materials.
• Conduct of non-inferiority clinical studies in support of the demonstration of human safety and effectiveness of the dried plasma product when compared to current standard of care.
• Activities related to securing regulatory approval by the FDA for a biologics license application (BLA) and/or De Novo class 3 medical device clearance (at the discretion of the FDA) with indications for transfusion and trauma.
• Developing cybersecurity compliance with section 524B of the FD&C Act (if using networked devices to manufacture the dried plasma product).

Requirements of the Project Information Paper

The intent of this RPI is to understand respondents’ interest and technology capabilities within the abovementioned focus area. MTEC is seeking input from both MTEC members and non-members via a Project Information Paper to be considered by the government. Project Information Papers will be shared with the reviewers under non-disclosure agreements. Project Information Papers may be submitted at any time during the submission period but no later than the due date and time specified on the cover page of this RPI using BIDS. See Addendum 2 of this RPI for further information regarding BIDS registration. MTEC membership is not required for submission of the Project Information Paper.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.