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Related Concept Videos

Antigens Involved in Adaptive Immunity01:26

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An antigen is any substance the immune system identifies as foreign and potentially harmful to the body, prompting an immune response. Antigens have two functional properties: immunogenicity and reactivity. Immunogenicity is the ability of an antigen to stimulate a specific immune response. At the same time, reactivity describes the antigen's ability to react with the cells and antibodies produced in response to it.
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Immunogenicity Risk Assessment for PEGylated Therapeutics.

Johanna R Mora1, Joleen T White2, Stephen L DeWall3

  • 1BioAnalytical Sciences, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA. johanna.mora@bms.com.

The AAPS Journal
|January 30, 2020
PubMed
Summary
This summary is machine-generated.

This study provides two case examples for assessing immunogenicity risk of PEGylated therapeutics during drug development. It offers strategies for Investigational New Drug applications, focusing on PEGylated enzymes and growth factors.

Keywords:
PEGylatedbiotherapeuticimmunogenicityrisk assessment

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Area of Science:

  • Biopharmaceutical Development
  • Immunogenicity Assessment
  • Drug Discovery

Background:

  • Polyethylene glycol (PEG) conjugation is a common strategy to improve therapeutic protein properties.
  • Assessing immunogenicity is critical for the safety and efficacy of PEGylated biologics.
  • Existing data on marketed PEGylated biologics provides context for risk assessment.

Purpose of the Study:

  • To illustrate methods for conducting immunogenicity risk assessments for PEGylated therapeutics.
  • To support Investigational New Drug (IND) applications and other drug development stages.
  • To present practical examples for PEGylated enzymes and growth factors.

Main Methods:

  • Case study 1: Immunogenicity risk assessment for a PEGylated enzyme with a narrow therapeutic window.
  • Case study 2: Immunogenicity risk assessment for a PEGylated growth factor.
  • Bioanalytical strategies supporting PEGylated therapeutics are summarized.

Main Results:

  • For PEGylated enzymes, utilizing a pharmacodynamic (PD) marker as a surrogate for neutralizing antibody assessment in Phase I is suggested.
  • For PEGylated growth factors, recommendations include monitoring additional analytes to mitigate immunogenicity risks related to endogenous counterparts.
  • The presented case studies offer practical guidance for risk management.

Conclusions:

  • Effective immunogenicity risk assessment is crucial for the successful development of PEGylated therapeutics.
  • Tailored bioanalytical strategies are essential for each specific PEGylated biologic.
  • The presented examples provide a framework for regulatory submissions and development decisions.