Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS

Biopharmaceutical products, the demand for which has grown significantly over the past decade, are synthesized by living cells. During the purification process, the substrates for growth, host cell components, and product variants must be removed. These impurities can be classified into three categories: product-related impurities (variants that differ from the desired product), process-related impurities (materials added to the process and cellular components), and contaminants (e.g., microorganisms).

Biopharmaceutical proteins are produced in cellular expression systems using a host cell organism. Impurities in such a biotherapeutic product are proteins derived from the proteome of the host cell. Removing host cell proteins (HCPs) from biologic products is vital for protecting drug efficacy, stability, and safety, but low-level residual HCPs may remain after purification. Detecting and quantifying these residual impurities is therefore essential for biopharmaceutical manufacturers.

Although the ‘gold standard’ technique for HCP analysis, immunoassays have long lead times and can be expensive to set up. Mass spectrometry (MS) is now recognized as an ideal complementary method to immunoassays, with faster set-up times and the ability to quantify and identify individual HCPs, reliably and accurately.

Read this article in BioPharm International’s July 2021 Biopharmaceutical Analysis eBook.

About the author

Stuart Pengelley is the senior scientist, Biopharma Application Development for Bruker Daltonics.

Article Details

BioPharm International
eBook: Biopharmaceutical Analysis, July 2021
July 2021
Pages: 26–30

Citations

When referring to this article, please cite it as S. Pengelley, “Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS,” BioPharm International Biopharmaceutical Analysis eBook (July 2021).