Literature DB >> 27639108

Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application.

P A De Sousa1, J M Downie2, B J Tye2, K Bruce2, P Dand2, S Dhanjal3, P Serhal4, J Harper3, M Turner5, M Bateman2.   

Abstract

From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources.
Copyright © 2016. Published by Elsevier B.V.

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Year:  2016        PMID: 27639108     DOI: 10.1016/j.scr.2016.08.011

Source DB:  PubMed          Journal:  Stem Cell Res        ISSN: 1873-5061            Impact factor:   2.020


  11 in total

1.  Isolation, Culture, Cryopreservation, and Preparation of Umbilical Cord-Derived Mesenchymal Stem Cells as a Final Cellular Product Under Good Manufacturing Practices-Compliant Conditions.

Authors:  Nurullah Aydoğdu; Olga Nehir Öztel; Erdal Karaöz
Journal:  Methods Mol Biol       Date:  2021

2.  Dynamic mass spectrometry probe for electrospray ionization mass spectrometry monitoring of bioreactors for therapeutic cell manufacturing.

Authors:  Mason A Chilmonczyk; Peter A Kottke; Hazel Y Stevens; Robert E Guldberg; Andrei G Fedorov
Journal:  Biotechnol Bioeng       Date:  2018-11-06       Impact factor: 4.530

3.  Isolation, Culture, Cryopreservation, and Preparation of Skin-Derived Fibroblasts as a Final Cellular Product Under Good Manufacturing Practice-Compliant Conditions.

Authors:  Nurullah Aydoğdu; Olga Nehir Öztel; Erdal Karaöz
Journal:  Methods Mol Biol       Date:  2021

4.  Off-the-Shelf, Immune-Compatible Human Embryonic Stem Cells Generated Via CRISPR-Mediated Genome Editing.

Authors:  Annie Kim; Kun-Gu Lee; Yeongbeen Kwon; Kang-In Lee; Heung-Mo Yang; Omer Habib; Jihun Kim; Sang-Tae Kim; Sung Joo Kim; Jin-Soo Kim; Dong-Youn Hwang
Journal:  Stem Cell Rev Rep       Date:  2021-01-09       Impact factor: 5.739

5.  High quality clinical grade human embryonic stem cell lines derived from fresh discarded embryos.

Authors:  Jinpei Ye; Nicola Bates; Despina Soteriou; Lisa Grady; Clare Edmond; Alex Ross; Alan Kerby; Philip A Lewis; Tope Adeniyi; Ronnie Wright; Kay V Poulton; Marcus Lowe; Susan J Kimber; Daniel R Brison
Journal:  Stem Cell Res Ther       Date:  2017-06-05       Impact factor: 6.832

6.  Turning Potential Into Action: Using Pluripotent Stem Cells to Understand Heart Development and Function in Health and Disease.

Authors:  Hananeh Fonoudi; Alexis Bosman
Journal:  Stem Cells Transl Med       Date:  2017-03-24       Impact factor: 6.940

7.  A Defined and Scalable Peptide-Based Platform for the Generation of Human Pluripotent Stem Cell-Derived Astrocytes.

Authors:  Sreedevi Raman; Gayathri Srinivasan; Nicholas Brookhouser; Toan Nguyen; Tanner Henson; Daylin Morgan; Joshua Cutts; David A Brafman
Journal:  ACS Biomater Sci Eng       Date:  2020-05-06

8.  Clinical Grade Human Pluripotent Stem Cell-Derived Engineered Skin Substitutes Promote Keratinocytes Wound Closure In Vitro.

Authors:  Sophie Domingues; Annabelle Darle; Yolande Masson; Manoubia Saidani; Emilie Lagoutte; Ana Bejanariu; Julien Coutier; Raif Eren Ayata; Marielle Bouschbacher; Marc Peschanski; Gilles Lemaitre; Christine Baldeschi
Journal:  Cells       Date:  2022-03-29       Impact factor: 6.600

Review 9.  Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy.

Authors:  Daniela Rehakova; Tereza Souralova; Irena Koutna
Journal:  Int J Mol Sci       Date:  2020-03-31       Impact factor: 5.923

Review 10.  Mesenchymal Stem Cell Secretome as an Emerging Cell-Free Alternative for Improving Wound Repair.

Authors:  Parinaz Ahangar; Stuart J Mills; Allison J Cowin
Journal:  Int J Mol Sci       Date:  2020-09-24       Impact factor: 5.923

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