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Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs
The last three decades have seen the biotherapeutic drug market evolve from promising concept to market dominance in a range of clinical indications. This growth has been spurred by the success of established drug classes like monoclonal antibodies, but also by the introduction of biosimilars, and m...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057416/ https://www.ncbi.nlm.nih.gov/pubmed/33948231 http://dx.doi.org/10.1017/cts.2020.493 |
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author | Vandivort, Tyler C. Horton, David B. Johnson, Steven B. |
author_facet | Vandivort, Tyler C. Horton, David B. Johnson, Steven B. |
author_sort | Vandivort, Tyler C. |
collection | PubMed |
description | The last three decades have seen the biotherapeutic drug market evolve from promising concept to market dominance in a range of clinical indications. This growth has been spurred by the success of established drug classes like monoclonal antibodies, but also by the introduction of biosimilars, and more recently, multiple novel cell and gene therapies. Biotherapeutic drug development presents many unique challenges, but unintended immune responses are among the most common reasons for program attrition. Anti-drug antibodies can impact the safety and efficacy of drug products, and related immune responses, like the cytokine release syndrome that occurred in the infamous TGN-1412 clinical trial, can be challenging to predict with nonclinical models. For this reason, it is important that development programs proceed with a scientifically grounded and measured approach to these responses. This process begins at the discovery stage with the application of “quality by design,” continues into the clinic with the development of quality assays and management strategies, and culminates in the effective presentation of this information in regulatory documents. This review provides an overview of some of the key strategic and regulatory considerations for biotherapeutics as they pertain to immunogenicity and related responses. |
format | Online Article Text |
id | pubmed-8057416 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-80574162021-05-03 Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs Vandivort, Tyler C. Horton, David B. Johnson, Steven B. J Clin Transl Sci Review Article The last three decades have seen the biotherapeutic drug market evolve from promising concept to market dominance in a range of clinical indications. This growth has been spurred by the success of established drug classes like monoclonal antibodies, but also by the introduction of biosimilars, and more recently, multiple novel cell and gene therapies. Biotherapeutic drug development presents many unique challenges, but unintended immune responses are among the most common reasons for program attrition. Anti-drug antibodies can impact the safety and efficacy of drug products, and related immune responses, like the cytokine release syndrome that occurred in the infamous TGN-1412 clinical trial, can be challenging to predict with nonclinical models. For this reason, it is important that development programs proceed with a scientifically grounded and measured approach to these responses. This process begins at the discovery stage with the application of “quality by design,” continues into the clinic with the development of quality assays and management strategies, and culminates in the effective presentation of this information in regulatory documents. This review provides an overview of some of the key strategic and regulatory considerations for biotherapeutics as they pertain to immunogenicity and related responses. Cambridge University Press 2020-06-15 /pmc/articles/PMC8057416/ /pubmed/33948231 http://dx.doi.org/10.1017/cts.2020.493 Text en © The Association for Clinical and Translational Science 2020 https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work. |
spellingShingle | Review Article Vandivort, Tyler C. Horton, David B. Johnson, Steven B. Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
title | Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
title_full | Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
title_fullStr | Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
title_full_unstemmed | Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
title_short | Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
title_sort | regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057416/ https://www.ncbi.nlm.nih.gov/pubmed/33948231 http://dx.doi.org/10.1017/cts.2020.493 |
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