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Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions
BACKGROUND: Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined....
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252207/ https://www.ncbi.nlm.nih.gov/pubmed/34210363 http://dx.doi.org/10.1186/s13287-021-02445-z |
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author | François, Pauline Rusconi, Giulio Arnaud, Laurent Mariotta, Luca Giraudo, Laurent Minonzio, Greta Veran, Julie Bertrand, Baptiste Dumoulin, Chloé Grimaud, Fanny Lyonnet, Luc Casanova, Dominique Giverne, Camille Cras, Audrey Magalon, Guy Dignat-George, Françoise Sabatier, Florence Magalon, Jeremy Soldati, Gianni |
author_facet | François, Pauline Rusconi, Giulio Arnaud, Laurent Mariotta, Luca Giraudo, Laurent Minonzio, Greta Veran, Julie Bertrand, Baptiste Dumoulin, Chloé Grimaud, Fanny Lyonnet, Luc Casanova, Dominique Giverne, Camille Cras, Audrey Magalon, Guy Dignat-George, Françoise Sabatier, Florence Magalon, Jeremy Soldati, Gianni |
author_sort | François, Pauline |
collection | PubMed |
description | BACKGROUND: Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. We analyzed stromal vascular fraction clinical batches from two independent good manufacturing practices-compliant manufacturing facilities, the Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), with the goal of defining appropriate and harmonized release acceptance criteria. METHODS: This retrospective analysis reviewed the biological characteristics of 364 batches of clinical-grade stromal vascular fraction. Collected data included cell viability, recovery yield, cell subset distribution of stromal vascular fraction, and microbiological quality. RESULTS: Stromal vascular fraction from SSCF cohort demonstrated a higher viability (89.33% ± 4.30%) and recovery yield (2.54 × 10(5) ± 1.22 × 10(5) viable nucleated cells (VNCs) per mL of adipose tissue) than stromal vascular fraction from AP-HM (84.20% ± 5.96% and 2.25 × 10(5) ± 1.11 × 10(5) VNCs per mL). AP-HM batches were significantly less contaminated (95.71% of sterile batches versus 74.15% for SSCF batches). The cell subset distribution was significantly different (higher proportion of endothelial cells and lower proportion of leukocytes and pericytes in SSCF cohort). CONCLUSIONS: Both centers agreed that a good manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80%, a minimum recovery yield of 1.50 × 10(5) VNCs per mL of adipose tissue, a proportion of adipose-derived stromal cells at least equal to 20%, and a proportion of leukocytes under 50%. In addition, a multiparameter gating strategy for stromal vascular fraction analysis is proposed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13287-021-02445-z. |
format | Online Article Text |
id | pubmed-8252207 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-82522072021-07-06 Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions François, Pauline Rusconi, Giulio Arnaud, Laurent Mariotta, Luca Giraudo, Laurent Minonzio, Greta Veran, Julie Bertrand, Baptiste Dumoulin, Chloé Grimaud, Fanny Lyonnet, Luc Casanova, Dominique Giverne, Camille Cras, Audrey Magalon, Guy Dignat-George, Françoise Sabatier, Florence Magalon, Jeremy Soldati, Gianni Stem Cell Res Ther Research BACKGROUND: Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. We analyzed stromal vascular fraction clinical batches from two independent good manufacturing practices-compliant manufacturing facilities, the Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), with the goal of defining appropriate and harmonized release acceptance criteria. METHODS: This retrospective analysis reviewed the biological characteristics of 364 batches of clinical-grade stromal vascular fraction. Collected data included cell viability, recovery yield, cell subset distribution of stromal vascular fraction, and microbiological quality. RESULTS: Stromal vascular fraction from SSCF cohort demonstrated a higher viability (89.33% ± 4.30%) and recovery yield (2.54 × 10(5) ± 1.22 × 10(5) viable nucleated cells (VNCs) per mL of adipose tissue) than stromal vascular fraction from AP-HM (84.20% ± 5.96% and 2.25 × 10(5) ± 1.11 × 10(5) VNCs per mL). AP-HM batches were significantly less contaminated (95.71% of sterile batches versus 74.15% for SSCF batches). The cell subset distribution was significantly different (higher proportion of endothelial cells and lower proportion of leukocytes and pericytes in SSCF cohort). CONCLUSIONS: Both centers agreed that a good manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80%, a minimum recovery yield of 1.50 × 10(5) VNCs per mL of adipose tissue, a proportion of adipose-derived stromal cells at least equal to 20%, and a proportion of leukocytes under 50%. In addition, a multiparameter gating strategy for stromal vascular fraction analysis is proposed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13287-021-02445-z. BioMed Central 2021-07-01 /pmc/articles/PMC8252207/ /pubmed/34210363 http://dx.doi.org/10.1186/s13287-021-02445-z Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research François, Pauline Rusconi, Giulio Arnaud, Laurent Mariotta, Luca Giraudo, Laurent Minonzio, Greta Veran, Julie Bertrand, Baptiste Dumoulin, Chloé Grimaud, Fanny Lyonnet, Luc Casanova, Dominique Giverne, Camille Cras, Audrey Magalon, Guy Dignat-George, Françoise Sabatier, Florence Magalon, Jeremy Soldati, Gianni Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
title | Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
title_full | Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
title_fullStr | Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
title_full_unstemmed | Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
title_short | Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
title_sort | inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252207/ https://www.ncbi.nlm.nih.gov/pubmed/34210363 http://dx.doi.org/10.1186/s13287-021-02445-z |
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