Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Jul;9(7):728-733.
doi: 10.1002/sctm.19-0389. Epub 2020 Mar 28.

Improving patient outcomes with regenerative medicine: How the Regenerative Medicine Manufacturing Society plans to move the needle forward in cell manufacturing, standards, 3D bioprinting, artificial intelligence-enabled automation, education, and training

Affiliations

Improving patient outcomes with regenerative medicine: How the Regenerative Medicine Manufacturing Society plans to move the needle forward in cell manufacturing, standards, 3D bioprinting, artificial intelligence-enabled automation, education, and training

Joshua Hunsberger et al. Stem Cells Transl Med. 2020 Jul.

Abstract

The Regenerative Medicine Manufacturing Society (RMMS) is the first and only professional society dedicated toward advancing manufacturing solutions for the field of regenerative medicine. RMMS's vision is to provide greater patient access to regenerative medicine therapies through innovative manufacturing solutions. Our mission is to identify unmet needs and gaps in regenerative medicine manufacturing and catalyze the generation of new ideas and solutions by working with private and public stakeholders. We aim to accomplish our mission through outreach and education programs and securing grants for public-private collaborations in regenerative medicine manufacturing. This perspective will cover four impact areas that the society's leadership team has identified as critical: (a) cell manufacturing and scale-up/out, respectively, for allogeneic and autologous cell therapies, (b) standards for regenerative medicine, (c) 3D bioprinting, and (d) artificial intelligence-enabled automation. In addition to covering these areas and ways in which the society intends to advance the field in a collaborative nature, we will also discuss education and training. Education and training is an area that is critical for communicating the current challenges, developing solutions to accelerate the commercialization of the latest technological advances, and growing the workforce in the rapidly expanding sector of regenerative medicine.

Keywords: stem cells; technology; tissue engineering; tissue regeneration.

PubMed Disclaimer

Conflict of interest statement

C.Z. declared employment and intellectual property rights with Akron Biotech and advisory role with CCRM, ARM Foundation, BioFlorida, ISCT, SCB. R.B. declared advisory role with PHC Corporation of North America, Konica Minolta, Inc. K.G. declared leadership position with Brightlands Chemelot Campus B.V. L.F. declared leadership position and stock ownership with Title21 Health Solutions. P.B. declared leadership position with RoosterBio Inc and equity interest in OrganaBio LLC. T.P. declared leadership position with Allevi, Inc. The other authors declared no potential conflicts of interest.

References

    1. Heathman TR, Nienow AW, McCall MJ, Coopman K, Kara B, Hewitt CJ. The translation of cell‐based therapies: clinical landscape and manufacturing challenges. Regen Med. 2015;10(1):49‐64. - PubMed
    1. Hunsberger J, Lundberg MS, Allickson J, Simon CG Jr, Zylberberg C, Beachy SH. Examining resources, initiatives, and regulatory pathways to advance regenerative medicine manufacturing. Curr Stem Cell Rep. 2019;5:162‐172.
    1. Mahdavi, B. , Abraham E., and Gottschalks U.. Myth and Misconception in Cell Therapy Manufacturing. 2019. https://www.pharmoutsourcing.com/Featured-Articles/180629-Myth-and-Misco....
    1. Mahdavi B, Gottschalk U, Trainor N, Smith T. The hype, hope and reality of personalization. Med Marker. https://themedicinemaker.com/manufacture/the-hype-hope-and-reality-of-pe....
    1. Eaker S, Armant M, Brandwein H, et al. Concise review: guidance in developing commercializable autologous/patient‐specific cell therapy manufacturing. Stem Cells Translational Medicine. 2013;2(11):871‐883. - PMC - PubMed