Výsledky vyhledávání - "Gary C. Du Moulin"

Voluntary Guidance for the Development of Tissue-Engineered Products

Autor: Ross Tubo, Deirdre D. Maxted, Gary C. Du Moulin, James Davis, Frank T. Gentile, Daniel R. Omstead, Lynn G. Baird, Lisa Christenson

Publikováno v: Tissue Engineering. 4:239-266

Tissue Engineering is an emerging field of medical research in which there is tremendous activity. Many of these products rely on the use of a cellular component co-formulated with a natural or synthetic biomaterial. At this time, though, there are n

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6fd2019e463a08b7dc8a1a43b321a917
https://doi.org/10.1089/ten.1998.4.239

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Validation of a Quality Assurance Program for Autologous Cultured Chondrocyte Implantation

Autor: Timothy A. Mayhew, George Kuniholm, Mary A. Senica, G. Rowland Williams, Gary C. Du Moulin

Publikováno v: Tissue Engineering. 4:325-334

The use of living human cells to facilitate repair of defects in structural tissues is a rapidly emerging treatment option. A quality assurance program based on U.S. Food and Drug Administration good manufacturing practice regulations and other guida

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9895ecccc91ad3604a659408c8087b3d
https://doi.org/10.1089/ten.1998.4.325

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Preliminary validation of an activation assay for ex vivo activated T cells utilized in cancer immunotherapy

Autor: Barry Caplan, Victor Liu, Mary Beth Clarke, Dylan Hamilton, Gary C. du Moulin, Bruce Babbitt, Joseph J. Goodwin

Publikováno v: Biotechnology and Bioengineering. 43:700-705

An in vitro assay that measures the activation level of ex vivo activated (EVA) T cells currently being used in the adoptive immunotherapy of metastatic renal cell carcinoma has been developed. This assay is based on the ability of activated, but not

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f231b6700a3f456cca1277090caf8e3e
https://doi.org/10.1002/bit.260430805

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Development of a regulatory strategy for the cellular therapies: an American perspective

Autor: Gary C du Moulin, Michiaki Morohashi

Publikováno v: Materials Science and Engineering: C. 13:15-17

A greater understanding in cell biology now makes it possible to cultivate, expand, and manipulate many kinds of living cells into innovative therapies. Since 1991, the US Food and Drug Administration (USFDA) has been very active in formulating polic

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a83432773bad4d8bb26d97b5b0ddc04a
https://doi.org/10.1016/s0928-4931(00)00171-5

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Validation of an automated method of endotoxin testing for use in the end-product testing of ex vivo activated T-lymphocytes used in a somatic cell therapy

Autor: Gary C. du Moulin, Yuan-Jin Shen, Zorina Pitkin, Prakash Chhugani, Aaron Chenette

Publikováno v: Biotechnology and bioengineering. 50(5)

The aim of this study was to compare two methods of endotoxin testing to optimize quality control testing methodologies required for the rapid and precise determination of pyrogenicity in cell or tissue products used in cellular therapies. An automat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::026f5b4e7071667de8d775f701f432fb
https://pubmed.ncbi.nlm.nih.gov/18627016

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A 3-year experience of quality control and quality assurance in the multisite delivery of a lymphocyte-based cellular therapy for renal cell carcinoma

Autor: Carla Charles, Brian Davies, Victor Liu, Letinh Ho, Jessica Stack, Yuan-Jin Shen, Gary C. du Moulin, Evelyn Conti, Judy Chew-Darke, Zorina Pitkin, Dylan Hamilton, Carolyn Cyr, Adrienne White

Publikováno v: Biotechnology and bioengineering. 43(8)

Autolymphocyte therapy (ALT) is outpatient-based adoptive immunotherapy using ex vivo-activated memory T-cells. To support the safe and reproducible delivery of ALT at three cell processing facilities (Boston, MA; Atlanta, GA; Orange, CA) we created

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e83d50063489be7033ccd2996389034b
https://pubmed.ncbi.nlm.nih.gov/18615793

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Overview of a quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience

Autor: Jean Ko Stewart, Yuan-Jin Shen, Gary C. du Moulin, Carla Charles, Dylan Hamilton, Zorina Pitkin, Evelyn Conti

Publikováno v: Cell Culture Engineering IV ISBN: 9789401041140

Somatic cell and gene therapy involve the application of biological technologies to an individual patient through the use of living cells which provide a therapeutic benefit (Aliski, 1991). Various forms of cellular and gene therapies are being devel

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7ecb4a7e00fbbe4c99eba8aa9b178a48
https://doi.org/10.1007/978-94-011-0257-5_39

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