Merck Offers Comprehensive Solution for Large Molecule QC Pipelines

Merck Lifescience's Dr Sundaram Palaniswamy discussed the analytical characterization of critical quality attributes (CQAs) in biologics during an interview.

The company offers a comprehensive solution for large molecule QC pipelines, covering sample prep to reference standards under one roof through its collaboration with Supelco.

Palaniswamy emphasized that biosimilar approval pathways vary by region. Both the US and EU require quality, non-clinical, and clinical comparability data against the originator.

To support India's biosimilar push, Merck provides on-site assistance, trial samples, and regulatory documentation for submissions to CDSCO, FDA, and EMA.