Regenerative Medicine: The Newest Cellular Therapy

Bita Nickkholgh; Darren Howard Martin Hickerson; Cynthia Wilkins; Julie Allickson; John Jackson

doi:10.1007/978-3-030-75537-9_33

Regenerative Medicine: The Newest Cellular Therapy

Bita Nickkholgh, Darren Howard Martin Hickerson, Cynthia Wilkins, Julie Allickson, John Jackson

Laboratory Medicine and Pathology

Research output: Chapter in Book/Report/Conference proceeding › Chapter

Abstract

Regenerative medicine is a relatively young field in introducing highly complex products in clinical scale with many challenges in advanced manufacturing, testing, and quality control platforms. This chapter describes the current workflows and challenges in regenerative medicine clinical manufacturing and discusses the potential Food and Drug Administration (FDA) regulatory paths for approval of regenerative medicine therapies for clinical use.

Original language	English (US)
Title of host publication	Cell Therapy
Subtitle of host publication	cGMP Facilities and Manufacturing: Second Edition
Publisher	Springer International Publishing
Pages	517-537
Number of pages	21
ISBN (Electronic)	9783030755379
ISBN (Print)	9783030755355
DOIs	https://doi.org/10.1007/978-3-030-75537-9_33
State	Published - Jan 1 2021

Keywords

Biomaterials
Regenerative medicine
Regulation of regenerative medicine
Scaffolds

ASJC Scopus subject areas

General Biochemistry, Genetics and Molecular Biology
General Medicine

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10.1007/978-3-030-75537-9_33

Cite this

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KW - Scaffolds

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Regenerative Medicine: The Newest Cellular Therapy

Abstract

Keywords

ASJC Scopus subject areas

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