Rapid, robust and reproducible Host Cell Protein analysis with Evosep One

In Biopharmaceutical drug development and production, Host Cell Proteins are the left overs of the cells used to produce the therapeutic protein in the final formulation. Regulatory authorities have increased their demands on the amount of these proteins that can be found in the final drug to an absolute minimum. This push from the regulatory bodies has pushed the producing companies from Elisa’s to Mass Spectrometry and Evosep is the ideal front end for the routine runs.

Sensitive, Rapid, Robust and Reproducible Workflow for Host Cell Protein Profiling in Biopharmaceutical Process Development

There is a growing industry and regulatory need to detect host cell proteins (HCPs) in the production of protein biopharmaceuticals, as certain HCPs can impact product stability, safely and efficacy, even at low levels.

We developed an HCP profiling workflow using an Evosep ONE LC system coupled to an Orbitrap Fusion Lumos mass spectrometer, which lead to HCP detection and quantification in a significantly shorter turnaround time.

The workflow can be readily implemented and adapted for different purposes to guide biopharmaceutical process development and enable better risk assessment of HCPs in drug substances.

Presenter: Jiao Ma, Ph.D. (Scientist II, AstraZeneca)

Achieving high-throughput HCP analysis for industrial enzyme manufacturing

Novozymes produces recombinant enzymes and microbial solution for a plethora of bio-based industries. Using the Evosep One and Bruker timsTOF Pro with automated data processing by GeneData, they have developed a streamlined HCP workflow that allows them to routinely handle up to 200 samples pr day.

Presenter: Anders Giessing (Senior Scientist hos Novozymes)