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Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods,

Jochem Gokemeijer¹, Yi Wen², Vibha Jawa³

¹Bristol Myers Squibb, 100 Binney Street, Cambridge, Massachusetts, 02143, USA. jochem.gokemeijer@bms.com.

The AAPS Journal

|June 2, 2023

Summary

This summary is machine-generated.

Pharmaceutical scientists use computational and laboratory methods to predict and assess drug immunogenicity risks early in development. These strategies inform clinical decisions and streamline manufacturing processes.

Keywords:

biotherapeutic harmonization immunogenicity risk in vitro assay preclinical development reference materials

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Area of Science:

Pharmaceutical Science
Drug Development
Immunogenicity Assessment

Background:

The Therapeutic Product Immunogenicity (TPI) community surveyed pharmaceutical scientists regarding immunogenicity risk assessment strategies.
The survey spanned 5 years and two phases, gathering data on early-stage drug development practices.

Purpose of the Study:

To understand current immunogenicity risk assessment strategies used prior to clinical development.
To identify trends in the use of in silico and in vitro methods for risk assessment.
To explore how these assessments inform drug developability, manufacturing, and clinical strategy.

Main Methods:

A two-phase survey distributed to pharmaceutical scientists.
Inquiry into the use of in silico algorithms and in vitro assay formats.
Data collection on the application of immunogenicity risk assessment findings.

Main Results:

Widespread adoption of high-throughput in silico algorithms and human immune cell-based assays.
Proteomics and specialized assays are utilized, particularly when the mechanism of action influences risk.
Tools also provide insights into Chemistry, Manufacturing, and Controls (CMC) risks, aiding process development.

Conclusions:

Immunogenicity risk assessments are integral to early drug development, influencing discovery, CMC, and non-clinical stages.
These assessments extend beyond early development to guide clinical strategy and bioanalysis.
The findings highlight a trend towards integrated strategies for de-risking drug development.