Recent Scientific Case Studies
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.
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
Comparative Study of Profiling Post-Translational Modifications of a Circulating Antibody Drug in Human With Different Capture Reagents
Quantitation and Pharmacokinetic Modeling of Therapeutic Antibody Quality Attributes in Human Studies
Assessing In Vivo Dynamics of Multiple Quality Attributes from a Therapeutic IgG4 Monoclonal Antibody Circulating in Cynomolgus Monkey