Potency evaluation of tissue engineered and regenerative medicine products

被引：29

作者：

Guthrie, Kelly ^{[1
]}

Bruce, Andrew ^{[1
]}

Sangha, Namrata ^{[1
]}

Rivera, Elias ^{[1
]}

Basu, Joydeep ^{[1
]}

机构：

[1] Tengion Inc, Proc Res & Translat, Winston Salem, NC 27103 USA

来源：

TRENDS IN BIOTECHNOLOGY | 2013年 / 31卷 / 09期

关键词：

potency; cell therapy; tissue engineering; regenerative medicine; RENAL-CELLS; RODENT MODEL; STEM; ASSAY; POPULATION; SURVIVAL; MATRIX; REPAIR;

D O I：

10.1016/j.tibtech.2013.05.007

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 [微生物学]; 090105 [作物生产系统与生态工程];

摘要：

Methodologies for the rigorous and quantitative evaluation of biological activity or potency are an essential aspect of the developmental pathway for all biologic product candidates. Such assays typically leverage key mechanistic pathways demonstrated to mediate observed therapeutic outcomes. Tissue engineered/regenerative medicine (TE/RM) therapeutics include cell based therapies as well as engineered tissues and neo-organs for which clarity regarding the mechanism or mechanisms of action may not be forthcoming. Here, we discuss how strategies for the development of potency assays for TE/RM product candidates may harness potential mechanisms of action or other therapeutically relevant bioactivity along with cell number and viability. As the pipeline for TE/RM product candidates expands through 2014 and beyond, the establishment of a defined framework for potency assays will facilitate successful translational outcomes.

引用

页码：505 / 514

页数：10

共 40 条

[1]

Andree B, 2013, TISSUE ENG PART B-RE, V19, P279, DOI [10.1089/ten.teb.2012.0583, 10.1089/ten.TEB.2012.0583]

[2]

[Anonymous], 2011, GUID IND POT TESTS C

[3]

Hepatocyte growth factor mediates mesenchymal stem cell-induced recovery in multiple sclerosis models [J].

Bai, Lianhua ;

Lennon, Donald P. ;

Caplan, Arnold I. ;

DeChant, Anne ;

Hecker, Jordan ;

Kranso, Janet ;

Zaremba, Anita ;

Miller, Robert H. .

NATURE NEUROSCIENCE, 2012, 15 (06) :862-U86

[4]

Basu J, 2012, DEV TISSUE ENG REGEN

[5]

Basu J, 2012, TISSUE ENG PT A, V18, P1025, DOI [10.1089/ten.tea.2011.0569, 10.1089/ten.TEA.2011.0569]

[6]

Developmental Engineering the Kidney: Leveraging Principles of Morphogenesis for Renal Regeneration [J].

Basu, Joydeep ;

Ludlow, John W. .

BIRTH DEFECTS RESEARCH PART C-EMBRYO TODAY-REVIEWS, 2012, 96 (01) :30-38

[7]

Functional Evaluation of Primary Renal Cell/Biomaterial Neo-Kidney Augment Prototypes for Renal Tissue Engineering [J].

Basu, Joydeep ;

Genheimer, Christopher W. ;

Rivera, Elias A. ;

Payne, Richard ;

Mihalko, Kim ;

Guthrie, Kelly ;

Bruce, Andrew T. ;

Robbins, Neil ;

McCoy, Darell ;

Sangha, Namrata ;

Ilagan, Roger ;

Knight, Toyin ;

Spencer, Thomas ;

Wagner, Belinda J. ;

Jayo, Manuel J. ;

Jain, Deepak ;

Ludlow, John W. ;

Halberstadt, Craig .

CELL TRANSPLANTATION, 2011, 20 (11-12) :1771-1790

[8]

Extension of bladder-based organ regeneration platform for tissue engineering of esophagus [J].

Basu, Joydeep ;

Mihalko, Kim L. ;

Payne, Richard ;

Rivera, Elias ;

Knight, Toyin ;

Genheimer, Christopher W. ;

Guthrie, Kelly I. ;

Sangha, Namrata ;

Jayo, Manuel J. ;

Jain, Deepak ;

Bertram, Timothy A. ;

Ludlow, John W. .

MEDICAL HYPOTHESES, 2012, 78 (02) :231-234

[9]

Basu J, 2011, REGEN MED, V6, P721, DOI [10.2217/RME.11.78, 10.2217/rme.11.78]

[10]

Expansion of the Human Adipose-Derived Stromal Vascular Cell Fraction Yields a Population of Smooth Muscle-Like Cells with Markedly Distinct Phenotypic and Functional Properties Relative to Mesenchymal Stem Cells [J].

Basu, Joydeep ;

Genheimer, Christopher W. ;

Guthrie, Kelly I. ;

Sangha, Namrata ;

Quinlan, Sarah F. ;

Bruce, Andrew T. ;

Reavis, Bethany ;

Halberstadt, Craig ;

Ilagan, Roger M. ;

Ludlow, John W. .

TISSUE ENGINEERING PART C-METHODS, 2011, 17 (08) :843-860

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