INSIGHTS ON FACILITY DESIGN

• 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.

• Understanding Fixed Variables And Working Within Their Constraints

  Some things are intrinsic, unchanging realities of a process — molecular complexity, product developability, and facility fit, to name a few. 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 these “non-pullable levers” of process development and advise teams on how to work within their boundaries.

• Enhancing Biological Indicators With Enzyme Indicators

  Achieve greater process assurance in decontamination cycles. Combining traditional indicators with rapid, quantitative enzyme data reveals performance trends to optimize validation.

• The Facility Master Planning Playbook With Herman Bozenhardt

  6/30/2026

  In this episode of “Better Biopharma,” host Tyler Menichiello is joined by friend-of-the-show Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance.

• How To Use Enzyme Indicators In An Aseptic Production Environment

  6/30/2026

  Discover how transitioning to quantitative validation data allows engineering teams to optimize decontamination timelines, slash system downtime, and minimize product carryover risks.

• Evaluation Of Novel Process Indicators For Hydrogen Peroxide Decontamination

  6/30/2026

  Immediate, quantifiable verification replaces seven-day incubation periods. Discover how enzyme-based indicators optimize hydrogen peroxide decontamination.

• Developing A Method To Assess Product And Personnel Safety In vH2O2 Decontamination Cycles

  6/30/2026

  Discover how ultra-sensitive spectroscopy transforms decontamination validation, revealing hidden efficiencies that safely cut facility downtime while ensuring absolute safety.

• The Benefits Of Aqueous Critical Cleaning

  6/22/2026

  Enhance pharmaceutical cleaning by aligning chemistry, process design, and monitoring to remove complex residues, reduce contamination risk, and ensure consistent, compliant performance.