Science-based assessment of source materials for cell-based medicines: Report of a stakeholders workshop

Glyn Stacey; Peter Andrews; Curtis Asante; Ivana Barbaric; Jaqueline Barry; Louise Bisset; Julian Braybrook; Robin Buckle; Amit Chandra; Peter Coffey; Sharon Crouch; Philip Driver; Amanda Evans; John Gardner; Patrick Ginty; Christopher Goldring; David C. Hay; Lyn Healy; Anna Hows; Claire Hutchinson; Helen Jesson; Tammy Kalber; Sue Kimber; Roland Leathers; Sarah Moyle; Trish Murray; Michael Neale; David Pan; B. Kevin Park; Raul Elgueta Rebolledo; Ian Rees; Marcelo N. Rivolta; Allan Ritchie; Eric J. Roos; Kourosh Saeb-Parsy; Bernd Schröder; Sujith Sebastien; Angela Thomas; Robert J. Thomas; Marc Turner; Ludovic Vallier; Loriana Vitillo; Andrew Webster; David Williams

doi:10.2217/rme-2018-0120

Science-based assessment of source materials for cell-based medicines: Report of a stakeholders workshop

Glyn Stacey^*, Peter Andrews, Curtis Asante, Ivana Barbaric, Jaqueline Barry, Louise Bisset, Julian Braybrook, Robin Buckle, Amit Chandra, Peter Coffey, Sharon Crouch, Philip Driver, Amanda Evans, John Gardner, Patrick Ginty, Christopher Goldring, David C. Hay, Lyn Healy, Anna Hows, Claire HutchinsonHelen Jesson, Tammy Kalber, Sue Kimber, Roland Leathers, Sarah Moyle, Trish Murray, Michael Neale, David Pan, B. Kevin Park, Raul Elgueta Rebolledo, Ian Rees, Marcelo N. Rivolta, Allan Ritchie, Eric J. Roos, Kourosh Saeb-Parsy, Bernd Schröder, Sujith Sebastien, Angela Thomas, Robert J. Thomas, Marc Turner, Ludovic Vallier, Loriana Vitillo, Andrew Webster, David Williams

^*Corresponding author for this work

Division of Cell Matrix Biology & Regenerative Medicine (L5)

Research output: Contribution to journal › Article › peer-review

Abstract

Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.

Original language	English
Pages (from-to)	935-944
Number of pages	10
Journal	Regenerative Medicine
Volume	13
Issue number	8
Early online date	29 Nov 2018
DOIs	https://doi.org/10.2217/rme-2018-0120
Publication status	Published - 1 Dec 2018

Keywords

ancillary materials
cell therapy
cell-based medicines
characterization regulatory science
efficacy
raw materials
regenerative medicine
safety
starting materials

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Stacey, G., Andrews, P., Asante, C., Barbaric, I., Barry, J., Bisset, L., Braybrook, J., Buckle, R., Chandra, A., Coffey, P., Crouch, S., Driver, P., Evans, A., Gardner, J., Ginty, P., Goldring, C., Hay, D. C., Healy, L., Hows, A., ... Williams, D. (2018). Science-based assessment of source materials for cell-based medicines: Report of a stakeholders workshop. Regenerative Medicine, 13(8), 935-944. https://doi.org/10.2217/rme-2018-0120

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abstract = "Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.",

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Stacey, G, Andrews, P, Asante, C, Barbaric, I, Barry, J, Bisset, L, Braybrook, J, Buckle, R, Chandra, A, Coffey, P, Crouch, S, Driver, P, Evans, A, Gardner, J, Ginty, P, Goldring, C, Hay, DC, Healy, L, Hows, A, Hutchinson, C, Jesson, H, Kalber, T, Kimber, S, Leathers, R, Moyle, S, Murray, T, Neale, M, Pan, D, Park, BK, Rebolledo, RE, Rees, I, Rivolta, MN, Ritchie, A, Roos, EJ, Saeb-Parsy, K, Schröder, B, Sebastien, S, Thomas, A, Thomas, RJ, Turner, M, Vallier, L, Vitillo, L, Webster, A & Williams, D 2018, 'Science-based assessment of source materials for cell-based medicines: Report of a stakeholders workshop', Regenerative Medicine, vol. 13, no. 8, pp. 935-944. https://doi.org/10.2217/rme-2018-0120

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T2 - Report of a stakeholders workshop

AU - Stacey, Glyn

AU - Andrews, Peter

AU - Asante, Curtis

AU - Barbaric, Ivana

AU - Barry, Jaqueline

AU - Bisset, Louise

AU - Braybrook, Julian

AU - Buckle, Robin

AU - Chandra, Amit

AU - Coffey, Peter

AU - Crouch, Sharon

AU - Driver, Philip

AU - Evans, Amanda

AU - Gardner, John

AU - Ginty, Patrick

AU - Goldring, Christopher

AU - Hay, David C.

AU - Healy, Lyn

AU - Hows, Anna

AU - Hutchinson, Claire

AU - Jesson, Helen

AU - Kalber, Tammy

AU - Kimber, Sue

AU - Leathers, Roland

AU - Moyle, Sarah

AU - Murray, Trish

AU - Neale, Michael

AU - Pan, David

AU - Park, B. Kevin

AU - Rebolledo, Raul Elgueta

AU - Rees, Ian

AU - Rivolta, Marcelo N.

AU - Ritchie, Allan

AU - Roos, Eric J.

AU - Saeb-Parsy, Kourosh

AU - Schröder, Bernd

AU - Sebastien, Sujith

AU - Thomas, Angela

AU - Thomas, Robert J.

AU - Turner, Marc

AU - Vallier, Ludovic

AU - Vitillo, Loriana

AU - Webster, Andrew

AU - Williams, David

PY - 2018/12/1

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N2 - Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.

AB - Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.

KW - ancillary materials

KW - cell therapy

KW - cell-based medicines

KW - characterization regulatory science

KW - efficacy

KW - raw materials

KW - regenerative medicine

KW - safety

KW - starting materials

U2 - 10.2217/rme-2018-0120

DO - 10.2217/rme-2018-0120

M3 - Article

C2 - 30488776

AN - SCOPUS:85058098339

SN - 1746-0751

VL - 13

SP - 935

EP - 944

JO - Regenerative Medicine

JF - Regenerative Medicine

IS - 8

ER -

Science-based assessment of source materials for cell-based medicines: Report of a stakeholders workshop

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Keywords

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