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Bio-Design and Manufacturing  2022 Vol.5 No.1 P.43-63

http://doi.org/10.1007/s42242-021-00154-3


Bioreactor design and validation for manufacturing strategies in tissue engineering


Author(s):  Diana Lim, Eric S. Renteria, Drake S. Sime, Young Min Ju, Ji Hyun Kim, Tracy Criswell, Thomas D. Shupe, Anthony Atala, Frank C. Marini, Metin N. Gurcan, Shay Soker, Joshua Hunsberger & James J. Yoo

Affiliation(s):  Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA; more

Corresponding email(s):   jyoo@wakehealth.edu

Key Words:  Bioreactor, Monitoring sensors and automation, Manufacturing, Tissue engineering, Regenerative medicine


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Diana Lim, Eric S. Renteria, Drake S. Sime, Young Min Ju, Ji Hyun Kim, Tracy Criswell, Thomas D. Shupe, Anthony Atala, Frank C. Marini, Metin N. Gurcan, Shay Soker, Joshua Hunsberger & James J. Yoo . Bioreactor design and validation for manufacturing strategies in tissue engineering[J]. Journal of Zhejiang University Science D, 2022, 5(1): 43-63.

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author="Diana Lim, Eric S. Renteria, Drake S. Sime, Young Min Ju, Ji Hyun Kim, Tracy Criswell, Thomas D. Shupe, Anthony Atala, Frank C. Marini, Metin N. Gurcan, Shay Soker, Joshua Hunsberger & James J. Yoo ",
journal="Journal of Zhejiang University Science D",
volume="5",
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pages="43-63",
year="2022",
publisher="Zhejiang University Press & Springer",
doi="10.1007/s42242-021-00154-3"
}

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Abstract: 
The fields of regenerative medicine and tissue engineering offer new therapeutic options to restore, maintain or improve tissue function following disease or injury. To maximize the biological function of a tissue-engineered clinical product, specific conditions must be maintained within a bioreactor to allow the maturation of the product in preparation for implantation. Specifically, the bioreactor should be designed to mimic the mechanical, electrochemical and biochemical environment that the product will be exposed to in vivo. Real-time monitoring of the functional capacity of tissue-engineered products during manufacturing is a critical component of the quality management process. The present review provides a brief overview of bioreactor engineering considerations. In addition, strategies for bioreactor automation, in-line product monitoring and quality assurance are discussed.

维克森林医学院Anthony Atala、James J. Yoo等 | 组织工程制造策略的生物反应器设计与验证(封面文章)

本综述论文聚焦用于组织工程的生物反应器的一些工程实践问题。再生医学和组织工程领域为疾病或损伤后的恢复、维持或改善组织功能提供了新的治疗选项。为了最大限度地提高组织工程临床产品的生物学功能,必须在生物反应器内保持特定条件,以允许产品培养成熟以达到植入条件。具体而言,生物反应器的设计应模仿所生产的组织将在体内暴露的机械、电化学和生化环境。在制造过程中对于组织工程产品的功能进行实时监控的能力是质量管理过程的关键组成部分。本综述简要概述了生物反应器的工程考量因素。此外,还讨论了生物反应器自动化、在线产品监控和质量保证的策略。

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