Pharmaceutical Analysis Blog

Discover Single-Digit ppm Host Cell Proteins in Purified Antibody Samples

Biosim_eSem_icon.pngRecombinant biopharmaceutical proteins are expressed in host cell systems that contain numerous host cell proteins (HCPs). Even after a series of purifications, low levels of HCPs can remain in the purified biotherapeutics, which could reduce drug efficacy and/or induce adverse patient immunoreactions. Thus, current regulations require HCPs to be identified and quantified.

In this study, we demonstrate that HCPs can be confidently identified using MS1 profiling and iterative directed MS strategy to serve as a superior acquisition method relative to the traditional shotgun MS/MS approach. Moreover, the beneficial use of different fractionation strategies as the first dimension using 2D-LC-MS for HCP analysis will be presented. The proposed workflow will facilitate the comprehensive identification of HCPs in biopharmaceutical products which enables the refinement of current biotherapeutic enrichment strategies.

Separation Science, in collaboration with Agilent Technologies, has developed an eSeminar covering the analysis of biotherapeutics and biosimilars. 

JordyHsaio.pngThis presentation is given by Jordy Hsiao (R&D Scientist, Agilent Technologies)

By attending this presentation you will learn about...

  • A workflow has been developed to identify and quantify low level HCPs using 2D-LC separation coupled to directed MS analysis
  • HCPs can be confidently identified using a MS1 profiling and iterative directed MS strategy to serve as a
  • Different first dimension fractionation strategies for 2D-LC-MS is beneficial for the comprehensive identification of HCPs

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