New approaches for characterization of the genetic stability of vaccine cell lines
The genetic stability of cell lines is a critical analytical attribute required to demonstrate the quality of cells over time. During cell passage, mutations can arise in the genomic DNA, potentially leading to changes in the final vaccine product. The identity and integrity of master cell banks, ex...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-07-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2017.1295191 |
| _version_ | 1797677609454141440 |
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| author | Siemon Ng Lucy Gisonni-Lex Ali Azizi |
| author_facet | Siemon Ng Lucy Gisonni-Lex Ali Azizi |
| author_sort | Siemon Ng |
| collection | DOAJ |
| description | The genetic stability of cell lines is a critical analytical attribute required to demonstrate the quality of cells over time. During cell passage, mutations can arise in the genomic DNA, potentially leading to changes in the final vaccine product. The identity and integrity of master cell banks, extended cell banks, complementing cell lines or recombinant cell lines expressing transgenes has to be tested throughout the production process by the vaccine manufacturer. Over the past few years, the traditional methods for evaluation of genetic stability have been replaced with molecular approaches including quantitative PCR, digital PCR and high throughput sequencing. However, these molecular-based approaches are used in research laboratories and not within a GMP-compliant environment. In this article, we briefly discuss some opportunities and challenges in characterization of the genetic stability of vaccine cell lines with these molecular-based approaches. |
| first_indexed | 2024-03-11T22:47:45Z |
| format | Article |
| id | doaj.art-506b4f04348e42c981c94184a375ba58 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:47:45Z |
| publishDate | 2017-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-506b4f04348e42c981c94184a375ba582023-09-22T08:17:49ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2017-07-011371669167210.1080/21645515.2017.12951911295191New approaches for characterization of the genetic stability of vaccine cell linesSiemon Ng0Lucy Gisonni-Lex1Ali Azizi2Microbiology & Virology PlatformMicrobiology & Virology PlatformMicrobiology & Virology PlatformThe genetic stability of cell lines is a critical analytical attribute required to demonstrate the quality of cells over time. During cell passage, mutations can arise in the genomic DNA, potentially leading to changes in the final vaccine product. The identity and integrity of master cell banks, extended cell banks, complementing cell lines or recombinant cell lines expressing transgenes has to be tested throughout the production process by the vaccine manufacturer. Over the past few years, the traditional methods for evaluation of genetic stability have been replaced with molecular approaches including quantitative PCR, digital PCR and high throughput sequencing. However, these molecular-based approaches are used in research laboratories and not within a GMP-compliant environment. In this article, we briefly discuss some opportunities and challenges in characterization of the genetic stability of vaccine cell lines with these molecular-based approaches.http://dx.doi.org/10.1080/21645515.2017.1295191cell linesgenetic stabilitymolecular approachestransgenesvaccines |
| spellingShingle | Siemon Ng Lucy Gisonni-Lex Ali Azizi New approaches for characterization of the genetic stability of vaccine cell lines Human Vaccines & Immunotherapeutics cell lines genetic stability molecular approaches transgenes vaccines |
| title | New approaches for characterization of the genetic stability of vaccine cell lines |
| title_full | New approaches for characterization of the genetic stability of vaccine cell lines |
| title_fullStr | New approaches for characterization of the genetic stability of vaccine cell lines |
| title_full_unstemmed | New approaches for characterization of the genetic stability of vaccine cell lines |
| title_short | New approaches for characterization of the genetic stability of vaccine cell lines |
| title_sort | new approaches for characterization of the genetic stability of vaccine cell lines |
| topic | cell lines genetic stability molecular approaches transgenes vaccines |
| url | http://dx.doi.org/10.1080/21645515.2017.1295191 |
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