Rakesh Aithal

Team Lead, Senior Scientist I, Pipeline Development, Global Biologics, United States Pharmacopeia at US Pharmacopeia

Speaker

Rakesh Aithal is currently working as a Team Lead, Senior Scientist I in the Pipeline Development Team of Global Biologics at USP. In this role, he works closely with scientific experts and stakeholders to develop physical and documentary standards used to support development and quality assessment of biopharmaceuticals with a major focus on protein therapeutics including monoclonal antibodies and antibody conjugates. He did his Ph.D. in Biomolecular Chemistry from Masaryk University and worked as a post-doctoral researcher in Cancer Research Center Marseille on the mechanistic understanding of meiotic recombination before transitioning into the biopharmaceutical industry. He has extensive expertise in a range of analytical methods for protein characterization and molecular biology techniques; and has published several research articles in peer reviewed journals. His expertise includes analytical method development, qualification, and validation along with comparative analytical similarity assessments to support biosimilar development.