Protagen expands HCP detection capacity

German CRO has invested in new machinery by ThermoFisher to offer high-performing mass spectrometry

PPS new high-performing mass spectrometer for wider-ranging detection. COpyright Protagen Protein Services GmbH

Protagen Protein Services (PPS), the German contract research organisation (CRO), has announced that a new Q Exactive HF-X, the high-performing mass spectrometer by ThermoFisher, started operational service last month.

The investment, Protagen said, aims to respond to current regulatory guidance where a mass spectrometry-based host cell protein (HCP) detection approach with faster, more accurate and wider-ranging detection is essential.

Protagen said the new equipment brings PPS to the next level of reproducible, accurate and sensitive analyses of majorly complex samples for different aspects of translational research and biopharma applications.

“We remain committed to positioning ourselves at the forefront, constantly looking for innovations and thus bringing the best technical and analytical service to our clients”, explained Dr Heiner Falkenberg, MS Team Leader at PPS.

Falkenberg continued: “We are improving HCP assessments significantly by means of the more decisive analytical technique of MS and we look forward to serving our clients.”

Analytical precision

The study of biomolecules for potential use as therapeutic agents requires the analysis of highly complex samples. This includes full characterization of complex biotherapeutics as well as comprehensive proteome profiling and quantitation.

Developers of biosimilars and new biological entities demand in-depth analysis, high-end data quality and analytical precision without compromising on robustness or speed.

Commenting on Thermo Fischer's device, Protagen said: "The new high-performing MS device not only allows to detect a higher number of proteins and peptides but also delivers much higher accuracy than previous models."

For Protagen, the extended capabilities offer an up to eight times improved signal to noise ratio for intact, native monoclonal antibody mass determination. A higher scan rate simultaneously enables the detection of multiple attributes (MAM) for peptide-based analysis like PTM characterization or glycoprofiling as well as it reaches a new level in characterizing protein impurities such as HCPs.

Contaminants detection with accuracy

Residual host cell proteins (HCPs) are ppm-level contaminants in biotherapeutics that may elicit an unpredictable immune response in patients and need to be monitored meticulously.

According to Protagen, the new high-performing instrument gives access to a more accurate approach that detects a wider population of HCPs than traditional ELISA technologies.

Falkenberg explained: “Due to our long-term experience, our intuitive specialised bioinformatics and to our newly acquired high-end MS technologies we are now able to offer advanced MS as a technique for the comprehensive analysis of HCPs in our clients’ products."

In DSP characterisation, the detectable HCPs in one mAb product were increased by a factor of about 4 (49 versus 12 HCPs) by using the newest technology. “The perspective that high-end MS technologies offer”, adds Falkenberg, “has been inspiring regulatory groups worldwide, who by now often recommend MS as an orthogonal approach to HCP-ELISA.”

In contrast to HCP-ELISA, which relies on the presence of polyclonal antibodies for positive HCP detection, the amplified qualities of high-performing mass spectrometers such as the ThermoFisher Q Exactive HF-X offer the advantage of detecting HCPs in a de novo manner, without specialised polyclonal antibody reagents or product-/process-specific method development.

“We remain committed to positioning ourselves at the forefront, constantly looking for innovations and thus bringing the best technical and analytical service to our clients”, emphasizes Dr. Heiner Falkenberg. “We are improving HCP assessments significantly by means of the more decisive analytical technique of MS and we look forward to serving our clients with our extended options in HCP detection.”

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