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GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use

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@article{a534bc0a4d03406696784719bfab8cf5,
title = "GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use",
abstract = "The emerging field of advanced therapy medicinal products (ATMP) holds promise of treating a variety of diseases. Adipose-derived stromal cells (ASCs) are currently being marketed or tested as cell-based therapies in numerous clinical trials. To ensure safety and efficacy of treatments, high-quality products must be manufactured. A good manufacturing practice (GMP) compliant and consistent manufacturing process including validated quality control methods is critical. Product design and formulation are equally important to ensure clinical feasibility. Here, we present a GMP-compliant, xeno-free, and semiautomated manufacturing process and quality controls, used for large-scale production of a cryopreserved off-the-shelf ASC product and tested in several phase I and II allogeneic clinical applications.",
author = "Mandana Haack-S{\o}rensen and Johansen, {Ellen M{\o}nsted} and H{\o}jgaard, {Lisbeth Drozd} and Jens Kastrup and Annette Ekblond",
note = "Copyright {\textcopyright} 2022 Mandana Haack-S{\o}rensen et al.",
year = "2022",
doi = "10.1155/2022/4664917",
language = "English",
volume = "2022",
pages = "4664917",
journal = "Stem Cells International",
issn = "1687-9678",
publisher = "Sage - Hindawi Access to Research",

}

RIS

TY - JOUR

T1 - GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use

AU - Haack-Sørensen, Mandana

AU - Johansen, Ellen Mønsted

AU - Højgaard, Lisbeth Drozd

AU - Kastrup, Jens

AU - Ekblond, Annette

N1 - Copyright © 2022 Mandana Haack-Sørensen et al.

PY - 2022

Y1 - 2022

N2 - The emerging field of advanced therapy medicinal products (ATMP) holds promise of treating a variety of diseases. Adipose-derived stromal cells (ASCs) are currently being marketed or tested as cell-based therapies in numerous clinical trials. To ensure safety and efficacy of treatments, high-quality products must be manufactured. A good manufacturing practice (GMP) compliant and consistent manufacturing process including validated quality control methods is critical. Product design and formulation are equally important to ensure clinical feasibility. Here, we present a GMP-compliant, xeno-free, and semiautomated manufacturing process and quality controls, used for large-scale production of a cryopreserved off-the-shelf ASC product and tested in several phase I and II allogeneic clinical applications.

AB - The emerging field of advanced therapy medicinal products (ATMP) holds promise of treating a variety of diseases. Adipose-derived stromal cells (ASCs) are currently being marketed or tested as cell-based therapies in numerous clinical trials. To ensure safety and efficacy of treatments, high-quality products must be manufactured. A good manufacturing practice (GMP) compliant and consistent manufacturing process including validated quality control methods is critical. Product design and formulation are equally important to ensure clinical feasibility. Here, we present a GMP-compliant, xeno-free, and semiautomated manufacturing process and quality controls, used for large-scale production of a cryopreserved off-the-shelf ASC product and tested in several phase I and II allogeneic clinical applications.

U2 - 10.1155/2022/4664917

DO - 10.1155/2022/4664917

M3 - Journal article

C2 - 35769340

VL - 2022

SP - 4664917

JO - Stem Cells International

JF - Stem Cells International

SN - 1687-9678

ER -

ID: 79154429