Course content

• Introduction to Biosimilars, Development and its role in Therapeutics, Cell Line Development and Upstream Bioprocessing, cell culture methods, clone selection and optimization, Bioreactors, Scale-up optimization Critical Quality Attributes for Biologics and Bio-similars, Glycosylation, De-amidation, Charge Variant analysis, Analytical Methods to measure Glycosylation, De-amidation, Charge Variant (AUC, CE, Mass spectrometry)
• Biophysical and analytical Characterization of Biologics products, Primary, secondary and tertiary structural analysis by various Biophysics Methods, Protein aggregation principle and analysis by DLS and SE-HPLC, Thermodynamic stability by DSC, ITC Downstream Purification for Biologics, Regulatory Approach for Biosimilars, Globalization of Biosimilar

References

• Introduction to Biologic and Biosimilar Product Development and Analysis, Nagel, Karen M. Springer, 2018
• Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development Editors: Gutka, Hiten J., Yang, Harry, Kakar, Shefali (Eds.) Springer, 2018