INSIGHTS ON UPSTREAM MANUFACTURING

  • Upstream Decisions Influence Downstream Challenges

    In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), answer the question, “What should developers be thinking about upstream to avoid downstream complications?” Klyushnichenko believes process-wide considerations like this begin earlier than cell line development at the product’s molecular construct itself.

  • Productivity Gains Upstream Apply Pressure Downstream

    In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), reflect on the progress that’s been made in terms of productivity gains and the “ceiling” that mAbs face, and how these upstream gains stress downstream operations. They also discuss how molecular complexity relates to challenges in purification.

  • Continuous Manufacturing As A Powerful Productivity Lever

    In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss the potential of perfusion and continuous manufacturing to improve productivity through smaller facility footprints and greater output over time. They also examine the challenges associated with these approaches, including cell-line stability, process monitoring, and the cost of operational mistakes.

  • Next-Generation Molecules Challenge Notions Of Yield And Performance

    In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss how the process-related associated with next-generation molecules like bispecifics and trispecifics complicate downstream purification efforts impurities (e.g., chain mispairings). They agree that mitigating these impurities is a developmental challenge both upstream and downstream.

UPSTREAM MANUFACTURING SOLUTIONS