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Recent Scientific Case Studies

LC-MS Based Host Cell Protein Analysis

Host cell proteins (HCPs) are common impurities in biologic drug products and are an obligatory critical quality attribute (CQA). The individual protein contaminants that make up the HCP profile, however, may vary significantly among individual biologic products and expression systems. As such, the HCP profile must be analyzed to identify even low levels of potentially concerning species in a biologic drug to ensure safety and efficacy. This whitepaper reviews fundamental aspects of HCPs pertaining to biologic drug development and current and emerging approaches to HCP analysis.

In Vivo CQA Mapping/Biotransformation Analysis

Historically, only general biologic drug PK levels have been assessed in clinical subjects, while related drug sub-structures and post translational modifications (PTMs) have rarely been examined in vivo. Recent advances in mass spectrometry and related sample preparations are enabling detailed characterization of biologic drugs extracted from biologic tissues including serum and plasma PK samples. This letter highlights how “In Vivo CQA Mapping” can be used to understand the relationship between specific drug structures and clinical parameters to accelerate and de-risk advanced biologic drug development programs.

Related Content: In Vivo Peer Reviewed Publications

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