US Government to Help Create Manufacturing Processes for Cell-Based Medicine
[Posted on: Friday, 8 April , 2016]

Regenerative medicine was identified as one of the top priorities for the US government in a report from the Subcommittee for Advanced Manufacturing of the National Science and Technology Council that advises the US President. The report acknowledged that cell-based medicine holds great potential to address critical medical issues related to cells, tissues, and organs particularly in the treatment of severe injuries, redirect immune functions, and organ transplants. Cell-based products can be used to create targeted treatments and diagnostic systems based on cells could speed up drug screening and findings new therapeutics. However, most of such therapies are at an early development phase in academia with little transition to commercially viable products primarily due to lack of sustainable reproducible scalable manufacturing technology. While there have been significant development and research in new cell based therapies, there is need for commercial scale manufacturing processes, raw material such as growth media, and equipment for such therapies. To aid this process, the report announced two goals. First, within 5 years, the government agencies will aim to create a prototype for large-scale fully automated cell production system for cells such as red and white blood cells that are grown in suspension. Second, in 10 years, systems to grow adherent cells for organs (e.g., heart, liver, gut, lung), ideally within their appropriate matrices will be developed. To achieve these goals funding will be provided to industry from DoD, FDA, NIH, NIST, DOE, National Nuclear Security Administration, NSF, and the Department of Veterans Affairs (VA). Funding will require demonstration of teams with advanced engineering skills, statistical and computational modeling, genomics, developmental biology, and biomanufacturing experience. Eight distinct funding programs were listed in the report for various areas of development such as exploratory research, manufacturing technology, development of measurements and standards for regenerative medicine, stem cells, cell-based and tissue-based treatment options, and diagnostic systems. Although the program seems ambitious and, it is, several of these programs have been in the works for several years. Details on the various grants available from the eight government agencies can be found at the links below: 

1. http://nsf.gov/pubs/2015/nsf15065/nsf15065.jsp 
2. http://www.nist.gov/amo/amtech/index.cfm 
3. http://www.nist.gov/mml/bbd/cell-therapies.cfm 
4. http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm127182.htm 
5. http://www.afirm.mil 
6. http://www.darpa.mil/program/microphysiological-systems and http://www.ncats.nih.gov/tissuechip 
7. http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-15-030.html 
8. http://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-ECB-HB-2016-09-JB/listing.html and http://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-ECB-HB-2016-08-JB/listing.html