Getting CHO host cell protein analysis up to speed. (February 2015)

• Record Type: Journal Article
• Authors: Leiss, Michael; Meier, Monika; Pester, Oxana; Aschner, Marion; Wedekind, Frank; Wiedmann, Michael; Wegele, Harald
• Is Part Of: Pharmaceutical bioprocessing. Volume 3:Number 1(2015)
• Page Start: 13
• Page End: 23
• Publication Date: 2015-02
• Subjects: Chinese hamster ovary host cell proteins -- cobas e 411 analyzer platform -- electrochemiluminescence immunoassay -- ELISA -- high-throughput quantification -- in-process control; Drugs -- Testing -- Periodicals; Drug development -- Periodicals; Clinical trials -- Periodicals; Biopharmaceutics -- Periodicals; 615.19
• DOI: 10.4155/pbp.14.55
• Languages: English
• ISSNs: 2048-9153

Abstract

Aim: Host cell proteins represent a major process-related impurity in recombinant biotherapeutics. Present work reports about a fully automated platform based on a cobas instrument (Roche Diagnostic GmbH, Mannheim, Germany) allowing high-throughput determination of host cell proteins.Materials & methods : The instrument combines automated sample preparation with electrochemiluminescence-based detection technology, facilitating highly sensitive and accurate detection.Results: Our data shows that the assay performs readily comparable to conventional ELISAs, but outperforms in speed, sample throughput and by its superior linear range. Comparison of ELISA and electrochemiluminescence immunoassay validation results from more than ten independent validations of clinical product testing methods supports our comparability claim.Conclusion: The electrochemiluminescence immunoassay represents a milestone for bioprocess impurity testing and abolishes the sample throughput limitations posed by conventional ELISA.