Host cell protein analysis

The analysis of host cell proteins (HCPs) is one the most important analytical requirements during process development of biopharmaceuticals.

Highly sensitive detection technologies are needed to detect HCPs at a sub-ppm level. Explore how, the Evosep One technology can speed up your HCP analysis.

RAPID, REPRODUCIBLE AND ROBUST HCP ANALYSIS WITH THE EVOSEP ONE

The growing field of biopharmaceutical drug development and production, has increased the demand for efficient and reproducible workflows for the detection of trace amounts of host cell proteins (HCPs) to ensure drug safety and purity.

Even very low-level HCPs can cause immunogenicity and impact drug quality, pushing the need for methods to rapidly monitor and identify multiple proteins in the same sample..

While ELISA has been the predominant method for HCP analysis due to its high sensitivity, LC/MS workflows have gained increased popularity, in contrast to ELISA, they allow for identification of many proteins at once, in a non-targeted manner. The Evosep One is the ideal front end to speed up your HCP analysis for routine screening.

Comprehensive analysis with more than 170 hcps identified 

At GlaxoSmithKline, they have implemented Evosep One in their HCP analysis workflow in combination with a Thermo Orbitrap Fusion Lumos mass spectrometer.

From a NIST monoclonal antibody reference material, they identify 55 unique HCPs with the 60 samples per day method, a depth comparable to previous reports in the literature, but in significantly shorter turnaround time of only 21 minutes compared to 8 hours.

This depth is further increased by high-pH offline fractionation with 171 HCPs in less than 3 hours of instrument time.

Read publication here

ADVANCED HIGH-THROUGHPUT HCP ANALYSIS FOR INDUSTRIAL ENZYME MANUFACTURING AT NOVOZYMES

Novozymes produces recombinant enzymes and microbial solutions for a plethora of bio-based industries.

To meet regulatory demands, they have developed a highly efficient and streamlined HCP workflow, which translate raw samples to data in less than 24 hours, with less than 2 hours of hands-on time.

With a focus on throughput, they have standardized on the Evosep One 200 samples per day method, combined with the Bruker timsTOF Pro and automated data processing by GeneData. This platform allows them to robustly identify 700-1200 intra-cellular microbial proteins in a sample with average CVs of less than 5% based on five replicate injections.

Source: Anders Giessing, Senior Scientist at Novozymes

MORE THAN 50 HCPs IN 21 MINUTES

Comprehensive HCP analysis is essential in early process development and stability testing as well as high throughput screening for enabling batch-to-batch fingerprinting. Fast analysis is enabled by the Evosep One combined with the Bruker timsTOF Pro, here demonstrated by the identification of 50+ HCPs with 3 or more peptides using the 60 samples per day method with high quality PASEF spectra.

This depth of HCP identification allows fingerprinting of biomanufacturing processes and the ability to easily identify the effects of changes in these procedures. Further implementation of DIA scan modes can lead to more efficient usage of the ion current and even more sensitive HCP analysis with short gradients. 

Read publication here

Evosep Webinar

RAPID, ROBUST AND REPRODUCIBLE HOST CELL PROTEIN ANALYSIS WITH EVOSEP ONE

available on demand 

In this webinar we will explore the possibilities of using the Evosep One technology to perform rapid, robust and reproducible HCP analysis.

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More research on Host Cell protein analysis 

Here you can see publications available on HCP analysis featuring Evosep One. For a full overview of publications published using the Evosep One Technology visit our Literature room here

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