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By Jianmei Kochling and Zhenyu Wang

Jianmei Kochling-finalZhenyu Wang-finalBiological medicine manufacturing is a complex process that involves cell culture and multiple purification steps. Biologic drugs are also highly sensitive to environmental changes such as temperature, pH, photo irradiation, oxidation, and mechanical force. Sophisticated tests and controls are required to demonstrate identity, quality, and safety. The major components of biological impurity profile can be both process-related and product-related. The challenges related to the characterization of these impurities are often related to understanding the analytical technologies and using them properly for different purposes.

Host cell protein (HCP) analysis has been one of the challenging tasks in biologics analysis, due to that fact that HCPs are present at low ppm level. Identification of unknown HCPs has been primarily relied on liquid chromatography–mass spectrometry (LC-MS). The LC-MS data can provide orthogonal support to the enzyme-linked immunosorbent assay (ELISA) quality control method, rendering strong regulatory justifications. Another challenge is understanding the mechanisms of protein aggregation. For those proteins that are prone to aggregation, probing higher order structure provides insight into potential control strategies for both drug substance and drug product. Application of multiple biophysical techniques are often needed to better characterize the degradation mechanism and provides opportunity to use orthogonal, higher throughput approaches for sample analysis.

The AAPS Stability and Pharmaceutical Impurities focus groups will jointly present the sunrise session “Recent Advance in the Technologies for Impurities and Degradation Products Characterization in Biological Products” at the 2016 AAPS National Biotechnology Conference on May 16–18 in Boston. This sunrise section will offer presentations around the above topics. This event is a great opportunity for those who would like to learn more about advanced analytical technologies for biological impurity analysis.

Jianmei Kochling, Ph.D., is director of Analytical Science and Technology, Global Manufacturing Science and Technology, Sanofi.
Zhenyu Wang, Ph.D., is director of Analytical Development, Biopharmaceutics & Specialty Dosage Forms Department at Merck. He currently serves as the chair of AAPS Pharmaceutical Impurities focus group.