Immunogenicity Risk Assessment for PEGylated Therapeutics.
AAPS J
; 22(2): 35, 2020 01 28.
Article
em En
| MEDLINE
| ID: mdl-31993858
ABSTRACT
The objective of this manuscript is to provide the reader with two examples on how to present an immunogenicity risk assessment for a PEGylated therapeutic as part of Investigational New Drug (IND) application or during other stages of the drug development process. In order to provide context to the bioanalytical strategies used to support the PEGylated therapeutics presented here, a brief summary of information available for marketed PEGylated biologics is provided. Two case studies are presented, a PEGylated enzyme and a PEGylated growth factor. For the former, the risk assessment covers how to deal with a narrow therapeutic window and suggestions to utilize a PD marker as surrogate for neutralizing antibody assessments in Phase I. The latter has recommendations on additional analytes that should be monitored to mitigate risk of immunogenicity to endogenous counterparts.
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Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Fenilalanina Amônia-Liase
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Polietilenoglicóis
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Succinimidas
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Produtos Biológicos
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Fator de Crescimento de Hepatócito
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Anticorpos Neutralizantes
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article