What question did this study set out to answer?

The aim is to develop a human induced pluripotent stem cell line compliant with Good Manufacturing Practice standards.

May 21, 2026Stem Cell Research0 citationsOpen Access

Generation of GMP-compliant hiPSC line CTEFi001-A

HDHulinova Daniela STSouralova Tereza KIKoutna Irena

Key Points

The aim is to develop a human induced pluripotent stem cell line compliant with Good Manufacturing Practice standards.
Manufactured hiPSC line in compliance with GMP standards
Used episomal reprogramming of blood cells from a healthy donor under aseptic, xeno-free, and chemically defined conditions
Fully characterized the hiPSC line for sterility, identity, and functionality.
The hiPSC line CTEFi001-A was successfully established and characterized.
All compliance metrics regarding sterility and identity were met and confirmed.

Abstract

A human induced pluripotent stem cell (hiPSC) line was manufactured in compliance with Good Manufacturing Practice (GMP) standards at the Cell and Tissue Engineering Facility, International Clinical Research Centre, St. Anne’s University Hospital, Brno. The line was established through episomal reprogramming of blood cells from a healthy donor under aseptic, xeno-free, and chemically defined conditions. The hiPSC line has been fully characterized with respect to sterility, identity, and functionality

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