Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics
A vast evolution of drug modalities has occurred over the last several decades. Novel modalities such as cell and gene therapies have proven to be efficacious for numerous clinical indications–primarily in rare disease and immune oncology. Because of this success, drug developers are heavily investi...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-12-01
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| Series: | International Journal of Molecular Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1422-0067/24/1/695 |
| _version_ | 1797625563626602496 |
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| author | Amanda Hays Jennifer Durham Bryan Gullick Nathan Rudemiller Thomas Schneider |
| author_facet | Amanda Hays Jennifer Durham Bryan Gullick Nathan Rudemiller Thomas Schneider |
| author_sort | Amanda Hays |
| collection | DOAJ |
| description | A vast evolution of drug modalities has occurred over the last several decades. Novel modalities such as cell and gene therapies have proven to be efficacious for numerous clinical indications–primarily in rare disease and immune oncology. Because of this success, drug developers are heavily investing in these novel modalities. Given the complexity of these therapeutics, a variety of bioanalytical techniques are employed to fully characterize the pharmacokinetics of these therapies in clinical studies. Industry trends indicate that quantitative PCR (qPCR) and multiparameter flow cytometry are both valuable in determining the pharmacokinetics, i.e. cellular kinetics, of cell therapies. This manuscript will evaluate the pros and cons of both techniques and highlight regulatory guidance on assays for measuring cellular kinetics. Moreover, common considerations when developing these assays will be addressed. |
| first_indexed | 2024-03-11T09:58:09Z |
| format | Article |
| id | doaj.art-b067d80d0df3448aab856320db7e888e |
| institution | Directory Open Access Journal |
| issn | 1661-6596 1422-0067 |
| language | English |
| last_indexed | 2024-03-11T09:58:09Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | International Journal of Molecular Sciences |
| spelling | doaj.art-b067d80d0df3448aab856320db7e888e2023-11-16T15:37:07ZengMDPI AGInternational Journal of Molecular Sciences1661-65961422-00672022-12-0124169510.3390/ijms24010695Bioanalytical Assay Strategies and Considerations for Measuring Cellular KineticsAmanda Hays0Jennifer Durham1Bryan Gullick2Nathan Rudemiller3Thomas Schneider4BioAgilytix Labs, 2300 Englert Drive, Durham, NC 27713, USABioAgilytix Labs, 2300 Englert Drive, Durham, NC 27713, USABioAgilytix Labs, 2300 Englert Drive, Durham, NC 27713, USABioAgilytix Labs, 2300 Englert Drive, Durham, NC 27713, USABioAgilytix Labs, 2300 Englert Drive, Durham, NC 27713, USAA vast evolution of drug modalities has occurred over the last several decades. Novel modalities such as cell and gene therapies have proven to be efficacious for numerous clinical indications–primarily in rare disease and immune oncology. Because of this success, drug developers are heavily investing in these novel modalities. Given the complexity of these therapeutics, a variety of bioanalytical techniques are employed to fully characterize the pharmacokinetics of these therapies in clinical studies. Industry trends indicate that quantitative PCR (qPCR) and multiparameter flow cytometry are both valuable in determining the pharmacokinetics, i.e. cellular kinetics, of cell therapies. This manuscript will evaluate the pros and cons of both techniques and highlight regulatory guidance on assays for measuring cellular kinetics. Moreover, common considerations when developing these assays will be addressed.https://www.mdpi.com/1422-0067/24/1/695pharmacokineticsPKcellular kineticsCAR-Tcell therapy |
| spellingShingle | Amanda Hays Jennifer Durham Bryan Gullick Nathan Rudemiller Thomas Schneider Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics International Journal of Molecular Sciences pharmacokinetics PK cellular kinetics CAR-T cell therapy |
| title | Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics |
| title_full | Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics |
| title_fullStr | Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics |
| title_full_unstemmed | Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics |
| title_short | Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics |
| title_sort | bioanalytical assay strategies and considerations for measuring cellular kinetics |
| topic | pharmacokinetics PK cellular kinetics CAR-T cell therapy |
| url | https://www.mdpi.com/1422-0067/24/1/695 |
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