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Related Experiment Video

Updated: Sep 12, 2025

Author Spotlight: Detecting Low-Abundant Host Cell Proteins in Drug Products Using Enrichment Beads and Limited Digestion

Author Spotlight: Detecting Low-Abundant Host Cell Proteins in Drug Products Using Enrichment Beads and Limited Digestion

Published on: January 19, 2024

Host Cell Protein Clinical Safety Risk Assessment-An Updated Industry Review.

Lisette Coye¹, Marisa A Jones², Georgeen Gaza-Bulseco³

¹Pfizer Inc., Pharmaceutical Sciences, Bothell, Washington, USA.

Biotechnology and Bioengineering

|August 4, 2025

Summary

This summary is machine-generated.

Host cell proteins (HCPs) are impurities in biopharmaceuticals that can affect patient safety. This study provides updated risk assessment frameworks for identifying and managing HCPs, ensuring safer drug products.

Keywords:

MS/HCP‐MS PLBL2 clinical safety risk high‐risk HCPs host cell proteins immunogenicity risk assessment

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An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry

An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry

Published on: April 17, 2018

Area of Science:

Biopharmaceutical Manufacturing
Analytical Chemistry
Regulatory Science

Background:

Host cell proteins (HCPs) are process-related impurities co-purifying with therapeutic proteins.
HCPs can impact patient safety through immunogenicity or toxicity, affecting efficacy and product quality.
Effective reduction and monitoring of HCPs are crucial for biopharmaceutical development.

Purpose of the Study:

To develop updated risk assessment frameworks for clinical safety risks of identified HCPs.
To incorporate regulatory considerations and industry experience into HCP risk management.
To provide guidance for decision-making in biopharmaceutical development and manufacturing.

Main Methods:

Review and build upon existing HCP risk assessment frameworks.
Incorporate industry expert knowledge and regulatory expectations.
Utilize a real-world case study to illustrate the application of updated frameworks.

Main Results:

Recommendations for conducting clinical risk assessment alongside product quality risk assessment.
Emphasis on evaluating biological activity and immunogenicity of concerning HCPs.
Highlighting the importance of cross-functional communication and collaboration.

Conclusions:

Comprehensive risk assessment frameworks are essential for managing HCPs in biopharmaceuticals.
Proactive identification and assessment of HCPs mitigate risks to patient safety.
Updated frameworks support regulatory compliance and continuous process improvement.