Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications

Patrick Wuchter; Karen Bieback; Hubert Schrezenmeier; Martin Bornhäuser; Lutz P Müller; Halvard Bönig; Wolfgang Wagner; Roland Meisel; Petra Pavel; Torsten Tonn; Peter Lang; Ingo Müller; Matthias Renner; Georg Malcherek; Rainer Saffrich; Eike C Buss; Patrick Horn; Markus Rojewski; Anita Schmitt; Anthony D Ho; Ralf Sanzenbacher; Michael Schmitt

doi:10.1016/j.jcyt.2014.04.002

Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications

Standard

Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications. / Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael.

In: CYTOTHERAPY, Vol. 17, No. 2, 2015, p. 128-139.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Wuchter, P, Bieback, K, Schrezenmeier, H, Bornhäuser, M, Müller, LP, Bönig, H, Wagner, W, Meisel, R, Pavel, P, Tonn, T, Lang, P, Müller, I, Renner, M, Malcherek, G, Saffrich, R, Buss, EC, Horn, P, Rojewski, M, Schmitt, A, Ho, AD, Sanzenbacher, R & Schmitt, M 2015, 'Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications', CYTOTHERAPY, vol. 17, no. 2, pp. 128-139. https://doi.org/10.1016/j.jcyt.2014.04.002

APA

Wuchter, P., Bieback, K., Schrezenmeier, H., Bornhäuser, M., Müller, L. P., Bönig, H., Wagner, W., Meisel, R., Pavel, P., Tonn, T., Lang, P., Müller, I., Renner, M., Malcherek, G., Saffrich, R., Buss, E. C., Horn, P., Rojewski, M., Schmitt, A., ... Schmitt, M. (2015). Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications. CYTOTHERAPY, 17(2), 128-139. https://doi.org/10.1016/j.jcyt.2014.04.002

Vancouver

Wuchter P, Bieback K, Schrezenmeier H, Bornhäuser M, Müller LP, Bönig H et al. Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications. CYTOTHERAPY. 2015;17(2):128-139. https://doi.org/10.1016/j.jcyt.2014.04.002

Bibtex

@article{dfb153a3f504409c8c497bbfcaa3e3df,

title = "Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications",

abstract = "BACKGROUND AIMS: Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process.METHODS: This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production.RESULTS: The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs.CONCLUSIONS: This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products.",

author = "Patrick Wuchter and Karen Bieback and Hubert Schrezenmeier and Martin Bornh{\"a}user and M{\"u}ller, {Lutz P} and Halvard B{\"o}nig and Wolfgang Wagner and Roland Meisel and Petra Pavel and Torsten Tonn and Peter Lang and Ingo M{\"u}ller and Matthias Renner and Georg Malcherek and Rainer Saffrich and Buss, {Eike C} and Patrick Horn and Markus Rojewski and Anita Schmitt and Ho, {Anthony D} and Ralf Sanzenbacher and Michael Schmitt",

year = "2015",

doi = "10.1016/j.jcyt.2014.04.002",

language = "English",

volume = "17",

pages = "128--139",

journal = "CYTOTHERAPY",

issn = "1465-3249",

publisher = "informa healthcare",

number = "2",

}

RIS

TY - JOUR

T1 - Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications

AU - Wuchter, Patrick

AU - Bieback, Karen

AU - Schrezenmeier, Hubert

AU - Bornhäuser, Martin

AU - Müller, Lutz P

AU - Bönig, Halvard

AU - Wagner, Wolfgang

AU - Meisel, Roland

AU - Pavel, Petra

AU - Tonn, Torsten

AU - Lang, Peter

AU - Müller, Ingo

AU - Renner, Matthias

AU - Malcherek, Georg

AU - Saffrich, Rainer

AU - Buss, Eike C

AU - Horn, Patrick

AU - Rojewski, Markus

AU - Schmitt, Anita

AU - Ho, Anthony D

AU - Sanzenbacher, Ralf

AU - Schmitt, Michael

PY - 2015

Y1 - 2015

N2 - BACKGROUND AIMS: Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process.METHODS: This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production.RESULTS: The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs.CONCLUSIONS: This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products.

AB - BACKGROUND AIMS: Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process.METHODS: This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production.RESULTS: The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs.CONCLUSIONS: This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products.

U2 - 10.1016/j.jcyt.2014.04.002

DO - 10.1016/j.jcyt.2014.04.002

M3 - SCORING: Journal article

C2 - 24856898

VL - 17

SP - 128

EP - 139

JO - CYTOTHERAPY

JF - CYTOTHERAPY

SN - 1465-3249

IS - 2

ER -