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Title: Dear Colleague Letter: Advanced Cellular Biomanufacturing (nsf16053)
       | NSF - National Science Foundation
Date:  3/1/2016

   NSF 16-053

Dear Colleague Letter: Advanced Cellular Biomanufacturing

   March 2, 2016

   Dear Colleague:

   Cell-based therapies, especially immune cells, have the potential to
   revolutionize human healthcare in various different contexts, including
   cancer and personalized medicine. For example, CAR (Chimeric antigen
   receptor) T-cell therapy for cancer requires modification, in vitro
   culture and expansion of human T-cells.   Manufacturing of therapeutic
   cells as the end product presents major engineering challenges.  New
   therapies and cell-based products depend critically on the development
   of robust, reliable and reproducible biomanufacturing technologies.

   Large-scale manufacturing of therapeutic cells has the potential to
   benefit millions of people with new life saving
   opportunities.  Advanced biomanufacturing is a field that builds upon
   groundbreaking discoveries in engineering and biology for producing the
   next generation of therapeutics. Cellular biomanufacturing is a very
   promising area of advanced biomanufacturing, and includes technological
   advances in large scale cell processing, cell preservation and
   distribution, and process monitoring and quality control.

   The National Science Foundation's (NSF) Directorate for Engineering
   (ENG) has placed a high priority on advanced biomanufacturing. The
   Chemical, Bioengineering, Environmental and Transport Systems (CBET)
   Division at NSF seeks EArly-Concept Grants for Exploratory Research
   (EAGER) proposals that address key challenges in cellular
   biomanufacturing science and engineering, with the intended use of the
   final cell product in cellular therapies.  Proposals that propose
   production of molecules as end products are discouraged.

   This Dear Colleague Letter (DCL) is aimed at identifying opportunities
   for leveraging and synthesizing conceptual scientific and technological
   innovation integrating disciplines such as immunology, cell biology and
   engineering, and to enhance developments in cellular biomanufacturing
   for the purposes of accelerating solutions to critical challenges in
   the field.

   Topics may include, but are not limited to:
     * Culture configurations and bioreactor approaches for reproducible
       cell expansion for potential therapeutic applications.
     * Optimal expansion of T cells specific for subdominant
       tumor-associated antigens and promoted expansion of T cells with
       central memory T-cell phenotype.
     * Scalable and cost-effective cell separation and purification
       methods and strategies for the final biomanufactured cell product.
     * Innovative platforms that reduce or eliminate cell product
       variability in developing robust biomanufacturing processes.
     * Methods for rapid, non-destructive characterization of cellular
       property and potency.
     * Mathematical methods and computational models that enable
       characterizing variability of cell properties including cell
       subtypes during biomanufacture, and which could be used for process
       tracking and/or validation.

   The proposed high-risk, high-impact projects must transcend approaches
   typically supported by the core research programs at NSF. Projects
   should have strong engineering and biological elements, integrating and
   advancing both disciplines. Academic-Industry collaborations are
   encouraged.  While proposed studies should be potentially
   transformative and may be considered "high-risk, high-payoff," they
   should also be compatible with the time and budget limits of the EAGER
   funding mechanism. Specifically, total budget requests for each
   project may be up to $300K for up to two years duration. For more
   information on EAGERs, please consult the [1]NSF Grant Proposal Guide
   (GPG).

EAGER SUBMISSION PROCESS

   EAGER proposals will be accepted from a Principal Investigator (PI) or
   a consortium of Investigators led by a PI at an eligible U.S.
   institution.

   Full EAGER proposals must be submitted to the Biomedical Engineering 
   program, PD 15-5345, by June 1, 2016, 5:00 PM 
   submitter's local time, via Fastlane or Grants.gov, following the NSF
   Grant Proposal Guide instructions, and should clearly indicate the
   reason that the proposed work would be appropriate for EAGER support.
   Please be sure that the title of your proposal starts with "EAGER:
   Biomanufacturing:" It is anticipated that all EAGER awards will be made
   in FY 2016.

   For more information or questions, please contact the CBET Division's
   Program Director for Biomedical Engineering, Carol Lucas, at
   [2]carlucas@nsf.gov or (703) 292-2161.

   Sincerely,

   JoAnn Slama Lighty
   Division Director
   Division of Chemical, Bioengineering, Environmental, and Transport
   Systems
   Directorate for Engineering

References

   1. http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpg
   2. mailto:carlucas@nsf.gov