Examining Resources, Initiatives, and Regulatory Pathways to Advance Regenerative Medicine Manufacturing

Hunsberger, Joshua; Lundberg, Martha S.; Allickson, Julie; Simon, Carl G.; Zylberberg, Claudia; Beachy, Sarah H.

doi:10.1007/s40778-019-00163-0

Cited by 3 publications

(2 citation statements)

References 24 publications

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“…Despite these advances, according to several technology road maps developed by the regenerative medicine industry, scalable and adaptable culture methods that employ cost-effective, chemically defined substrates are still needed to generate the large quantities of cells required for downstream applications in disease modeling, drug screening, and cell-based therapies. − More specifically, current biomanufacturing techniques are limited by the following. First, current differentiation protocols employ undefined substrates such as Matrigel or extracellular matrix proteins (ECMPs) isolated from animal sources. − In turn, such heterogeneous xenogeneic components not only pose a risk of transmitting adventitious pathogens but also suffer from batch-to-batch variability, which might limit their compatibility with downstream clinical applications. , Second, conventional astrocyte generation strategies employ traditional two-dimensional (2D) culture techniques, which do not allow for production of large cell quantities needed for drug screening and cell-based therapies.…”

Section: Introductionmentioning

confidence: 99%

A Defined and Scalable Peptide-Based Platform for the Generation of Human Pluripotent Stem Cell-Derived Astrocytes

Raman

Srinivasan

Brookhouser

et al. 2020

ACS Biomater. Sci. Eng.

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Astrocytes comprise the most abundant cell type in the central nervous system (CNS) and play critical roles in maintaining neural tissue homeostasis. In addition, astrocyte dysfunction and death has been implicated in numerous neurological disorders such as multiple sclerosis, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and Parkinson's disease (PD). As such, there is much interest in using human pluripotent stem cell (hPSC)-derived astrocytes for drug screening, disease modeling, and regenerative medicine applications. However, current protocols for generation of astrocytes from hPSCs are limited by the use of undefined xenogeneic components and two-dimensional (2D) culture surfaces, which limits their downstream applications where large-quantities of cells generated under defined conditions are required. Here, we report the use of a completely synthetic, peptidebased substrate that allows for the differentiation of highly pure populations of astrocytes from several independent hPSC lines, including those derived from patients with neurodegenerative disease. This substrate, which we demonstrate is compatible with both conventional 2D culture formats and scalable microcarrier (MC)-based technologies, leads to the generation of cells that express high levels of canonical astrocytic markers as well as display properties characteristic of functionally mature cells including production of apolipoprotein E (ApoE), responsiveness to inflammatory stimuli, ability to take up amyloid-β (Aβ), and appearance of robust calcium transients. Finally, we show that these astrocytes can be cryopreserved without any loss of functionality. In the future, we anticipate that these methods will enable the development of bioprocesses for the production of hPSC-derived astrocytes needed for biomedical research and clinical applications.

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Section: Introductionmentioning

confidence: 99%

A Defined and Scalable Peptide-Based Platform for the Generation of Human Pluripotent Stem Cell-Derived Astrocytes

Raman

Srinivasan

Brookhouser

et al. 2020

ACS Biomater. Sci. Eng.

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“…A recent perspective article examines the resources, initiatives, and regulatory pathways to advance regenerative medicine manufacturing. 2 A critical challenge facing the field is developing processes and platform technologies that can cost effectively scale-up/out the expansion of cells for allogenic (on the order of billions) or autologous (patient specific). 3,4 Upstream and downstream manufacturing processes are also critical to scale-related analysis, as each is dependent on maintaining the desired phenotype throughout the manufacturing process.…”

Section: Cell Manufacturing and Scale-up/outmentioning

confidence: 99%

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

Hunsberger¹,

Simon

Zylberberg

et al. 2020

Stem Cells Translational Medicine

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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. K E Y W O R D S stem cells, technology, tissue engineering, tissue regenerationThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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Revisiting technological entrepreneurship research: An updated bibliometric analysis of the state of art

Majdouline

Baz

Jebli

2022

Technological Forecasting and Social Change

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Examining Resources, Initiatives, and Regulatory Pathways to Advance Regenerative Medicine Manufacturing

Cited by 3 publications

References 24 publications

A Defined and Scalable Peptide-Based Platform for the Generation of Human Pluripotent Stem Cell-Derived Astrocytes

A Defined and Scalable Peptide-Based Platform for the Generation of Human Pluripotent Stem Cell-Derived Astrocytes

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

Revisiting technological entrepreneurship research: An updated bibliometric analysis of the state of art

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