BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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26 BioPharm International eBook July 2021 Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS Sophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics. B iopharmaceutical 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 compo- nents, and product variants must be removed. These impurities can be classified into three categories: product-re- lated 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 expres- sion systems using a host cell organism. Impurities in such a biotherapeutic product are proteins derived from the proteome of the host cell. Since the beginning of biotherapeutic/biologic production in the 1980s, host cell proteins (HCPs) have been recognized as critical quality attributes (CQAs) (1), which are described as "A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product qual- ity" by the International Council for Harmonisation (ICH) Q8(R2) (2). Process-related impurities, such as HCPs, may pose a direct risk to the safety of a biotherapeutic, either directly through toxicity, hypersensitivity, endotoxin shock, or biological activity of the HCP, or through immunogenicity, where HCPs may be direct targets of the immune response. The stability of biother- apeutics may also be compromised by the presence of residual HCPs. They can contain enzymes, such as oxidases and lipases, S TUAR T PENGELLE Y is senior scientis t, Bio phar ma A p plic ation Development, Bruker Daltonics. STUART PENGELLEY Elena Pankova - Biopharmaceutical Analysis Impurity Analysis

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