Author Archives: Kumar Dhanasekharan

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Emerging Technology Trends in Biologics Development: A Contract Development and Manufacturing Perspective

For a contract development and manufacturing organization (CDMO), process development and manufacturing of recombinant proteins must be linked because of tight timelines driven by client expectations. Those are in turn driven by a need for rapid progression to clinical testing. Early in process development, the choice of raw materials needs to reflect existing supply chain and manufacturing infrastructure, but remain suitable for scaling up to meet future needs. One approach is to establish platform processes for a class of molecules…

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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,…