Author Archives: Zaneer Segu


Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

Over the past decade, monoclonal antibodies have become mainstream therapeutics for treating a broad range of conditions from autoimmune disorders to cancer. Part of this evolution is increasing time and cost pressure on biopharmaceutical companies to bring new drugs to market 1, 2. Additionally, companies now routinely engineer and screen molecules for developability and manufacturability during discovery before selecting a final candidate molecule. The biosimilar development paradigm also demands significantly more bioanalytical analysis during initial cell-line and process development. Thus,…