Insights On Facility Design

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Validating VH2O2 Decontamination Cycles For Product And Personnel Safety 6/30/2026

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

  7. 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.

  8. Particle Removal In Chemical Processing 6/22/2026

    Particles can form or enter during processing, affecting performance. Layered filtration — from early reduction to final polishing — protects operations and improves consistency.

  9. Particle Removal In Drug Production 6/22/2026

    Optimize particle removal with filtration strategies tailored to process conditions, boosting efficiency, protecting product quality, and reducing contamination risk in small molecule manufacturing.

  10. 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.