TY - JOUR
T1 - The Generation of Six Clinical-Grade Human Embryonic Stem Cell Lines
AU - Crook, Jeremy Micah
AU - Peura, Teija Tuulikki
AU - Kravets, Lucy
AU - Bosman, Alexis Gina
AU - Buzzard, Jeremy James
AU - Horne, Rachel
AU - Hentze, Hannes
AU - Dunn, Norris Ray
AU - Zweigerdt, Robert
AU - Chua, Florence
AU - Upshall, Alan
AU - Colman, Alan
PY - 2007/11/15
Y1 - 2007/11/15
N2 - The edict for producing clinically compliant human embryonic stem cells (hESCs) necessitates adherence to global ethical standards for egg procurement and embryo donation, conformity to regulations controlling clinical-grade cell and tissue product development, and compliance with current good tissue and manufacturing practices (cGTPs and cGMPs, respectively). For example, the U.S. FDA Center for Biologics Evaluation and Research recently promulgated regulations regarding human cells and cellular-based products (HCT/Ps) intended for tissue repair or replacement. Issued under Code of Federal Regulations parts 1270 and 1271 (Code of Federal Regulations, 2006a, 2006b), the rules are broadened by requirements for donor selection and cGMPs for HCT/Ps. By adhering to regulations and in anticipation of future standards, we have generated six clinical-grade hESC lines. Here we describe their manufacture, from embryo procurement to line characterization, including sterility and pathogen testing (Figure 1). To our knowledge, the lines represent the first to have been produced in compliance with international regulatory requirements, suitable for therapeutic use.
AB - The edict for producing clinically compliant human embryonic stem cells (hESCs) necessitates adherence to global ethical standards for egg procurement and embryo donation, conformity to regulations controlling clinical-grade cell and tissue product development, and compliance with current good tissue and manufacturing practices (cGTPs and cGMPs, respectively). For example, the U.S. FDA Center for Biologics Evaluation and Research recently promulgated regulations regarding human cells and cellular-based products (HCT/Ps) intended for tissue repair or replacement. Issued under Code of Federal Regulations parts 1270 and 1271 (Code of Federal Regulations, 2006a, 2006b), the rules are broadened by requirements for donor selection and cGMPs for HCT/Ps. By adhering to regulations and in anticipation of future standards, we have generated six clinical-grade hESC lines. Here we describe their manufacture, from embryo procurement to line characterization, including sterility and pathogen testing (Figure 1). To our knowledge, the lines represent the first to have been produced in compliance with international regulatory requirements, suitable for therapeutic use.
UR - https://www.scopus.com/pages/publications/35848930381
U2 - 10.1016/j.stem.2007.10.004
DO - 10.1016/j.stem.2007.10.004
M3 - Letter
C2 - 18938745
AN - SCOPUS:35848930381
SN - 1934-5909
VL - 1
SP - 490
EP - 494
JO - Cell Stem Cell
JF - Cell Stem Cell
IS - 5
ER -
