Insights On Facility Design

31. Optimize Every Step In Your Biopharma Site 7/5/2026

    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.

32. 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.

33. Continuous Manufacturing As A Powerful Productivity Lever 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), 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.

34. Understanding Fixed Variables And Working Within Their Constraints 7/1/2026

    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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. Designing For cGMP Compliance: Facility Requirements And Best Practices 6/26/2026

    Integrating process flows, HVAC controls, and cleanability during initial cleanroom planning ensures cGMP compliance and mitigates long-term contamination risks.