Traditional biologics, new biotherapeutics formats and biosimilars are flooding discovery and development pipelines. Thus analytical function is evolving rapidly, demanding high-throughput and high-resolution tools, focused biomolecular and biophysical assays and tailored analytical and impurity profiling strategies. The Analytics & Impurities pipeline convenes world experts for in-depth perspectives on the most critical characterization steps for traditional and new protein formats and stability issues arising from particles, protein aggregates, and extractables and leachables during manufacturing processing and storage.
Characterization of Biotherapeutics
Detection and Characterization of Particulates and Impurities
Extractables and Leachables