Quality Assurance for Biomanufactured Regenerative Medicine Products (Qual-Regen)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Research and Development Command (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.

Applications for this RPP are being solicited for the Defense Health Agency, J‐9 Research and Development (DHA R&D) Directorate. As directed by the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), the DHA J‐9 R&D Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation for which funds are being made available to advance the state-of-the-art in biomedical manufacturing.

The JPC-8/CRMRP, DHA RDA, and OASD(HA) have identified a need for regenerative medicine prototype development efforts and manufacturing technologies. Current Good Manufacturing Practice (cGMP) quality is a requirement by the U.S. Food and Drug Administration (FDA) and European Medicines Agency to provide patients with clinical-grade products that are safe and have defined quality characteristics. However, process standardization and robust manufacturing techniques are lacking in regenerative medicine, which will continue to impede progress in advancing regenerative medicine based technologies and treatments toward the clinic. This is likely due to the immaturity of the regenerative medicine field, which could benefit from the development and advancement of many manufacturing capabilities.

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 Government contractor collaboration. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.

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 of the RPP 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.

To meet the intent of this RPP, proposed prototype solutions must address at least one of the three Focus Areas listed above.

Scope of Work

To be provided initially by the Offeror at the time of submission. Submitted information is subject to change through negotiation if the Government selects for funding.

Points of Contact

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