Measuring IgG Titer: Need for Real-Time Results, Customization and High Comparability to HPLC

By on July 18, 2016
Dr. Christian Weilke, Ph.D.,

The successful implementation of PAT (process analytical technology) involves analysis and monitoring of key attributes within the bioprocess including measuring IgG titer.   When measuring critical process parameters, such as IgG titer, the need for high quality data AND real-time access are very important.

  • While HPLC is the gold standard, is it accessible at all stages (early cell line development to manufacturing) and at the frequency desired?
  • What is the impact of getting IgG titer in minutes versus days, without preparing and sending samples for HPLC analysis?
Graph 1: Internal Roche Diagnostics Data

Graph 1: Internal Roche Diagnostics Data

Measuring IgG Titer:

Roche Custom Biotech offers an IgG assay available on the Cedex Bio and Cedex Bio HT Analyzers which provides fast and accurate measurement of human IgG in cell culture and fermentation media and delivers results that are highly comparable to HPLC (see Graph 1). The assay is based on a turbidimetric method using antibodies directed against the common human Fc region. Additionally, the assay calibration can be adapted specifically to the individual IgG molecule, providing optimal accuracy for artificially engineered antibodies with uncommon structures as well. When compared to gold standard methods like HPLC, the data shows close correlation with decreased turnaround times and less need for manual intervention.

The Cedex Bio and Cedex Bio HT Analyzers provide access to 21 assays including Glucose, Lactate, Ammonia, Glutamate, Glutamine, LDH, IgG, Iron, Acetate, Phosphate, Optical Density, etc, and a test menu that has continuously expanded according to the needs of the market. The systems offer on-board dilution, minimal hands-on maintenance, low sample volume requirement and wide measuring ranges. The Cedex Bio Analyzer is appropriate for low to medium sample throughput while the Cedex Bio HT Analyzer is suited for higher throughput holding up to 90 samples at once (with continuous loading), and offering advanced workflow integration capabilities.

Have questions?

This week, Dr. Christian Weilke, Ph.D., International Product Manager at Roche Custom Biotech, will be answering your questions regarding the IgG assay and the Cedex Bio and Bio HT Analyzers. Christian holds a Ph.D. in chemistry and joined Roche in 1999. Since 2010, he has been working in Custom Biotech holding several different positions, and is currently responsible for the Pharma In-process Control portfolio.

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