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Medical Technology Enterprise Consortium (MTEC) -- Quality Assurance for Biomanufactured Regenerative Medicine Products (Qual-Regen)
This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC support of the USAMRDC Clinical and Rehabilitative Medicine Research Program (CRMRP). Military relevance is a critical component of Solution Brief submission. Strategic and tactical oversight for the award(s) supported by this RPP will be provided by the Joint Program Committee 8 (JPC‐8)/CRMRP.
This RPP focuses on quality management of biomanufacturing processes and/or development of a prototype for a universal biomanufactured product or process. Applications should clearly state innovative solutions for the biomanufacturing of regenerative medicine products and regulatory strategies to obtain FDA clearances or approvals, if appropriate. This RPP offers the opportunity for industry funding to join the project as it leads to stronger leveraging of Governmentcontractor collaboration. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.
Solutions Brief Due Date: April 14, 2020
Areas of Interest
The major objective of this RPP is to overcome current challenges in biomanufacturing of regenerative medicine products and enable successful cGMP manufacturing and clinical translation of regenerative medicine based therapies. To accomplish this we are seeking solutions for quality management of manufacturing processes or prototypes for cell, tissue, or organ bioengineering technologies. This RPP specifically targets solutions to the following Focus Areas (see Section 5 for more details):
1) Processing technologies for quality management of acellular matrices or Stem Cell (SC)- derived cell based therapies
2) Manufactured universal acellular matrix
3) Innovative manufacturing process for SC-derived cell based therapies
Offerors must be MTEC Members in good standing.