Considering 'clonality': A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development
| Autor: | Joel T. Welch, N. Sarah Arden |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Pharmacology Biological Products Potential impact General Immunology and Microbiology Bioengineering Context (language use) General Medicine Computational biology Regulatory Application Applied Microbiology and Biotechnology Cell Line 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Biopharmaceutical Drug Development Mammalian cell Animals Humans 030212 general & internal medicine Business Biological Specimen Banks Biotechnology |
| Zdroj: | Biologicals. 62:16-21 |
| ISSN: | 1045-1056 |
| Popis: | There has been much recent focus on the regulatory emphasis and the relative importance surrounding clonal derivation of mammalian production cell lines used in the manufacture of recombinant DNA-derived biopharmaceuticals. This interest has led to an ongoing discussion between regulators and industry on how this topic is evaluated and the role it plays in the development of a new biopharmaceutical. Herein the authors describe that the clonal derivation of the production cell line is a factor with potential impact on product quality, and thus should not be considered separately from, but rather in the context of all elements comprising the control strategy necessary to support approval of a regulatory application. Considerations for how clonal derivation of cell banks and clonal variation thereof may be viewed during the lifecycle of a biopharmaceutical product is provided. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect