Description

Biotherapeutics, particularly antibodies, are currently the fastest growing pharmaceuticals. Ideally, biotherapeutics are formulated in aqueous solutions and are often a great challenge due physical and chemical stability issues. This course addresses the latest trends and challenges in biologics formulation with a focus on the important role of preformulation in understanding the biological molecule itself for greater "formulatability" and "developability". The course will feature interactive discussions on early formulation screening, thorough biophysical and analytical characterization, improving the feedback loop in the early formulation-development interface, overcoming aggregation and other heterogeneity challenges, and improving overall product profile, In addition, the course will also cover an optimization of the formulation process through rational iterative approach and in-depth case studies, As a whole, this course focuses on providing you with additional tools and knowledge to help streamline solutions to formulation and stability issues for biologics.