INSIGHTS ON FACILITY DESIGN

• Starting With The End In Mind

  Complex biologics need scalable, GMP-ready development from the start. Early decisions, scientific continuity, and strong partnerships help reduce delays and rework.

• Optimize Every Step In Your Biopharma Site

  Bridge the gap between validation and cleanroom execution. Learn how proactive site surveys, residue management, and robust CAPA programs resolve compliance deficiencies and ensure audit readiness.

• 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.

• Productivity Gains Upstream Apply Pressure Downstream

  7/1/2026

  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.

• Enhancing Biological Indicators With Enzyme Indicators

  6/30/2026

  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.