International Journal on Science and Technology

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Matrix-Aware Optimization of Carboxypeptidase B (CPB) Treatment Using Human Serum to Support Cation-Exchange (CEX) Method Development for Monoclonal Antibodies and Fusion Proteins

Author(s) Jasmine Jinugu
Country United States
Abstract Charge variant profiling is a critical component of analytical control strategies for monoclonal antibodies (mAbs) and fusion proteins, with cation-exchange chromatography (CEX) serving as a widely used reference technique for resolving acidic, main, and basic species. [18] [23] [24] A common contributor to basic species is C-terminal Lys/Arg heterogeneity, which can be normalized analytically through carboxypeptidase B (CPB) treatment to remove C-terminal basic residues prior to charge profiling. [13] [14] [15] However, CPB performance can be impacted by matrix effects, including inhibition by formulation components or biological matrices, motivating a “matrix-aware” optimization strategy. [13] This manuscript presents a research-style, publication-ready framework for optimizing CPB activity in the presence of human serum (as a representative complex matrix) and integrating that optimization into CEX method development for both mAbs and fusion proteins. [13] [18] [25] We summarize relevant enzyme properties and kinetics, propose a Design of Experiments (DoE) approach for robust CPB condition selection, and outline how optimized CPB treatment improves interpretability of CEX charge variant profiles while supporting fit-for-purpose validation per ICH guidance. [2] [22] Figures include workflow schematics, illustrative kinetics and DoE response surfaces, and representative CEX chromatogram presentations (simulated placeholders intended to be replaced by experimental chromatograms). [18] [25]
Keywords Carboxypeptidase B, CPB; CPB2/CPU, thrombin-activatable fibrinolysis inhibitor, monoclonal antibodies, fusion proteins, charge variants, cation exchange chromatography, pH gradient, matrix effects, serum inhibition, method development; ICH Q2(R2). [1] [6] [7] [18] [22]
Field Engineering
Published In Volume 17, Issue 2, April-June 2026
Published On 2026-04-04
DOI https://doi.org/10.71097/IJSAT.v17.i2.11024
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