Dr Sundaram Palaniswamy, Senior Global Product Manager – Analytical Chemistry, Merck Lifescience

Speaker in this video:
Dr Sundaram Palaniswamy, Senior Global Product Manager – Analytical Chemistry, Merck Lifescience

Topic: Analytical Characterization of Critical Quality Attributes (CQAs) in Biologics

Key Highlights:
[1] Merck and Supelco cover the entire large molecule QC pipeline, sample prep to reference standards, under one roof.

[2] Biosimilar approval pathways differ by region, both the US and EU require quality, non-clinical, and clinical comparability data against the originator.

[3] For India’s biosimilar push, Merck offers on-site support, trial samples, and regulatory documentation for CDSCO, FDA, and EMA submissions