Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide
For process optimisation Design of Experiments (DoE) has long been established as a more powerful strategy than a One Factor at a Time approach. Nevertheless, DoE is not widely used especially in the field of cell-based bioassay development although it is known that complex interactions often exist....
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | SLAS Discovery |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2472555222137056 |
| _version_ | 1797944113402740736 |
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| author | J Solzin K Eppler B Knapp H Buchner E Bluhmki |
| author_facet | J Solzin K Eppler B Knapp H Buchner E Bluhmki |
| author_sort | J Solzin |
| collection | DOAJ |
| description | For process optimisation Design of Experiments (DoE) has long been established as a more powerful strategy than a One Factor at a Time approach. Nevertheless, DoE is not widely used especially in the field of cell-based bioassay development although it is known that complex interactions often exist. We believe that biopharmaceutical manufacturers are reluctant to move beyond standard practices due to the perceived costs, efforts, and complexity.We therefore introduce the integrated DoE (ixDoE) approach to target a smarter use of DoEs in the bioassay setting, specifically in optimising resources and time. Where in a standard practice 3 to 4 separate DoEs would be performed, our ixDoE approach includes the necessary statistical inference from only a single experimental set. Hence, we advocate for an innovative, ixDoE approach accompanied by a suitable statistical analysis strategy and present this as a practical guide for a typical bioassay development from basic research to biopharmaceutical industry. |
| first_indexed | 2024-04-10T20:34:32Z |
| format | Article |
| id | doaj.art-fb4a0a035ab9401cb357ba99f24ea9f7 |
| institution | Directory Open Access Journal |
| issn | 2472-5552 |
| language | English |
| last_indexed | 2024-04-10T20:34:32Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | SLAS Discovery |
| spelling | doaj.art-fb4a0a035ab9401cb357ba99f24ea9f72023-01-25T04:15:55ZengElsevierSLAS Discovery2472-55522023-01-012812938Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guideJ Solzin0K Eppler1B Knapp2H Buchner3E Bluhmki4Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany; Corresponding author.Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), GermanyBoehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), GermanyStaburo GmbH, 81549 Munich, GermanyBoehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany; Biberach University of Applied Sciences, D-88400 Biberach (Riss), GermanyFor process optimisation Design of Experiments (DoE) has long been established as a more powerful strategy than a One Factor at a Time approach. Nevertheless, DoE is not widely used especially in the field of cell-based bioassay development although it is known that complex interactions often exist. We believe that biopharmaceutical manufacturers are reluctant to move beyond standard practices due to the perceived costs, efforts, and complexity.We therefore introduce the integrated DoE (ixDoE) approach to target a smarter use of DoEs in the bioassay setting, specifically in optimising resources and time. Where in a standard practice 3 to 4 separate DoEs would be performed, our ixDoE approach includes the necessary statistical inference from only a single experimental set. Hence, we advocate for an innovative, ixDoE approach accompanied by a suitable statistical analysis strategy and present this as a practical guide for a typical bioassay development from basic research to biopharmaceutical industry.http://www.sciencedirect.com/science/article/pii/S2472555222137056Cell-based bioassayPotency assayDesign of experiments (DoE)OptimisationRobustness |
| spellingShingle | J Solzin K Eppler B Knapp H Buchner E Bluhmki Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide SLAS Discovery Cell-based bioassay Potency assay Design of experiments (DoE) Optimisation Robustness |
| title | Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide |
| title_full | Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide |
| title_fullStr | Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide |
| title_full_unstemmed | Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide |
| title_short | Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide |
| title_sort | optimising cell based bioassays via integrated design of experiments ixdoe a practical guide |
| topic | Cell-based bioassay Potency assay Design of experiments (DoE) Optimisation Robustness |
| url | http://www.sciencedirect.com/science/article/pii/S2472555222137056 |
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