Five Critical Areas that Combat High Costs and Prolonged Development Times for Regenerative Medicine Manufacturing

被引：6

作者：

Hunsberger J.G. ^{[1
]}

Goel S. ^{[1
]}

Allickson J. ^{[1
]}

Atala A. ^{[1
]}

机构：

[1] Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, NC

来源：

Current Stem Cell Reports | 2017年 / 3卷 / 2期

关键词：

3D printing; Body-on-a-chip; Precision medicine; Stem cells; Tissue engineering;

D O I：

10.1007/s40778-017-0083-7

中图分类号：

学科分类号：

摘要：

Purpose of Review: The purpose of this review is to examine five stages of process improvement in bioengineering of cellular products that could facilitate standardization and accelerate progress through the regulatory pathways and together make such treatments more widely available. Recent Findings: We present solutions to reduce costs, promote standardization, and enable acceleration through the required regulatory pathways. Summary: Regenerative medicine-based technologies and products have the potential to revolutionize the practice of medicine and become the next standard of care. We identify current barriers that are limiting the widespread availability of these potential life-saving treatments and platform technologies. One central barrier is the cost of manufacturing these regenerative medicine-based technologies and products at commercial scale. © 2017, Springer International Publishing AG.

引用

页码：77 / 82

页数：5

共 10 条

[1]

Radenkovic D., Solouk A., Seifalian A., Personalized development of human organs using 3D printing technology, Med Hypotheses, 87, pp. 30-33, (2016)

[2]

Culme-Seymour E.J., Mason K., Vallejo-Torres L., Carvalho C., Partington L., Crowley C., Et al., Cost of stem cell-based tissue-engineered airway transplants in the United Kingdom: case series, Tissue Eng Part A, 22, 3-4, pp. 208-213, (2016)

[3]

Karnieli O., Friedner O.M., Allickson J.G., Zhang N., Jung S., Fiorentini D., Et al., A consensus introduction to serum replacements and serum-free media for cellular therapies, Cytotherapy, 19, 2, pp. 155-169, (2017)

[4]

Eaker S., Abraham E., Allickson J.G., Brieva T.A., Baksh D., Heathman T.R.J., Et al., Bioreactors for cell therapies: current status and future advances, Cytotherapy, 19, pp. 9-18, (2017)

[5]

Skardal A., Devarasetty M., Kang H.W., Mead I., Bishop C., Shupe T., Et al., A hydrogel bioink toolkit for mimicking native tissue biochemical and mechanical properties in bioprinted tissue constructs, Acta Biomater, 25, pp. 24-34, (2015)

[6]

Chimene D., Lennox K.K., Kaunas R.R., Gaharwar A.K., Advanced bioinks for 3D printing: a materials science perspective, Ann Biomed Eng, 44, 6, pp. 2090-2102, (2016)

[7]

Mir T.A., Nakamura M., Three-dimensional bioprinting: toward the era of manufacturing human organs as spare parts for healthcare and medicine, Tissue Eng Part B Rev, (2017)

[8]

Mazur P., Freezing of living cells: mechanisms and implications, Am J Phys, 247, 3, pp. C125-C142, (1984)

[9]

Tanaka R., Takahashi N., Nakamura Y., Hattori Y., Ashizawa K., Otsuka M., In-line and real-time monitoring of resonant acoustic mixing by near-infrared spectroscopy combined with chemometric technology for process analytical technology applications in pharmaceutical powder blending systems, Anal Sci, 33, 1, pp. 41-46, (2017)

[10]

Zhang Y.S., Aleman J., Shin S.R., Kilic T., Kim D., Mousavi Shaegh S.A., Et al., Multisensor-integrated organs-on-chips platform for automated and continual in situ monitoring of organoid behaviors, Proc Natl Acad Sci U S A, 114, 12, pp. E2293-E2302, (2017)

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