Technology Digest: HCP detection and quantitation: a review of ELISA, MS and Antibody Affinity Extraction immunoaffinity chromatography

In the context of biological drugs, host cell proteins (HCPs) represent a heterogeneous group of process-related impurities. Whilst many are benign, some HCPs are immunogenic, meaning their presence in an administered biotherapeutic induces an unwanted immune response in the patient. Some interact with the active drug component, whilst others can reduce effective product dosage. Given that HCPs can pose a risk to patients and affect the efficacy and stability of biological drugs, the quantity and nature of residual HCPs in a drug substance are considered to be critical quality attributes industrywide.

In this Tech Digest, we explore HCPs as contaminants in biotherapeutics and the methods available for detecting and quantifying them.

HCPs contaminants biological drugsThis eBook includes:

  • TECHNOLOGY DIGEST: HCP detection and quantitation: a review of ELISA, MS and Antibody Affinity Extraction™ immunoaffinity chromatography

  • REVIEW: Biopharmaceutical quality control with mass spectrometry

  • EDITORIAL: Analytical challenges and advancements in bioanalysis of therapeutic proteins

  • REVIEW: Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products

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