Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different?
Mesenchymal stem/stromal cells (MSCs) are multipotent stem cells that can be isolated from bone marrow, adipose tissue, the umbilical cord, dental pulp, etc. These cells have unique properties that give them excellent therapeutic potential, including immunoregulation, immunomodulation, and tissue re...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-05-01
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| Series: | Heliyon |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844023031535 |
| _version_ | 1797815583241142272 |
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| author | Duc M. Hoang Quyen T. Nguyen Trang T.K. Phan Anh T.L. Ngo Phuong T. Pham Trung Q. Bach Phuong T.T. Le Hoa T.P. Bui Liem Nguyen Thanh |
| author_facet | Duc M. Hoang Quyen T. Nguyen Trang T.K. Phan Anh T.L. Ngo Phuong T. Pham Trung Q. Bach Phuong T.T. Le Hoa T.P. Bui Liem Nguyen Thanh |
| author_sort | Duc M. Hoang |
| collection | DOAJ |
| description | Mesenchymal stem/stromal cells (MSCs) are multipotent stem cells that can be isolated from bone marrow, adipose tissue, the umbilical cord, dental pulp, etc. These cells have unique properties that give them excellent therapeutic potential, including immunoregulation, immunomodulation, and tissue regeneration functions. MSC-based products are considered advanced therapy medicinal products (ATMPs) under European regulations (1394/2007); thus, they must be manufactured under good manufacturing practices and via effective manufacturing methods. The former can be achieved via a proper laboratory design and compliance with manufacturing protocols, whereas the latter requires an approach that ensures that the quality of the products is consistent regardless of the manufacturing procedure. To meet these daunting requirements, this study proposes an exchangeable approach that combines optimized and equivalent manufacturing processes under the Quality by Design (QbD) principle, allowing investigators to convert from small laboratory-scale to large-scale manufacturing of MSC-based products for clinical applications without altering the quality and quantity of the cell-based products. |
| first_indexed | 2024-03-13T08:25:00Z |
| format | Article |
| id | doaj.art-8bc012666a7d497898fd7707214495c8 |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-03-13T08:25:00Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-8bc012666a7d497898fd7707214495c82023-05-31T04:46:05ZengElsevierHeliyon2405-84402023-05-0195e15946Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different?Duc M. Hoang0Quyen T. Nguyen1Trang T.K. Phan2Anh T.L. Ngo3Phuong T. Pham4Trung Q. Bach5Phuong T.T. Le6Hoa T.P. Bui7Liem Nguyen Thanh8Vinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet Nam; Corresponding author.Vinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec High Tech Center, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec High Tech Center, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet NamVinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet Nam; College of Health Science, Vin University, Vinhomes Ocean Park, Gia Lam District, Hanoi 12400, Viet Nam; Vinmec International Hospital – Times City, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet Nam; Corresponding author. Vinmec Research Institute of Stem Cell and Gene Technology, Vinmec Healthcare System, 458 Minh Khai, Hanoi 11622, Viet Nam.Mesenchymal stem/stromal cells (MSCs) are multipotent stem cells that can be isolated from bone marrow, adipose tissue, the umbilical cord, dental pulp, etc. These cells have unique properties that give them excellent therapeutic potential, including immunoregulation, immunomodulation, and tissue regeneration functions. MSC-based products are considered advanced therapy medicinal products (ATMPs) under European regulations (1394/2007); thus, they must be manufactured under good manufacturing practices and via effective manufacturing methods. The former can be achieved via a proper laboratory design and compliance with manufacturing protocols, whereas the latter requires an approach that ensures that the quality of the products is consistent regardless of the manufacturing procedure. To meet these daunting requirements, this study proposes an exchangeable approach that combines optimized and equivalent manufacturing processes under the Quality by Design (QbD) principle, allowing investigators to convert from small laboratory-scale to large-scale manufacturing of MSC-based products for clinical applications without altering the quality and quantity of the cell-based products.http://www.sciencedirect.com/science/article/pii/S2405844023031535Mesenchymal stem/stromal cellsCellular manufacturing processQuantum cell expansion systemHYPERflaskQuality by design |
| spellingShingle | Duc M. Hoang Quyen T. Nguyen Trang T.K. Phan Anh T.L. Ngo Phuong T. Pham Trung Q. Bach Phuong T.T. Le Hoa T.P. Bui Liem Nguyen Thanh Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? Heliyon Mesenchymal stem/stromal cells Cellular manufacturing process Quantum cell expansion system HYPERflask Quality by design |
| title | Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? |
| title_full | Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? |
| title_fullStr | Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? |
| title_full_unstemmed | Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? |
| title_short | Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? |
| title_sort | advanced cell based products generated via automated and manual manufacturing platforms under the quality by design principle are they equivalent or different |
| topic | Mesenchymal stem/stromal cells Cellular manufacturing process Quantum cell expansion system HYPERflask Quality by design |
| url | http://www.sciencedirect.com/science/article/pii/S2405844023031535 |
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