Insights On Facility Design

  1. Identifying Worst-Case Locations Assessing Homogeneity Using BIs And EIs 7/27/2026

    Combine quantitative enzyme indicators, computational fluid dynamics, and traditional biological indicators to improve VPHP isolator validation and process confidence.

  2. Enhancing Biological Indicators With Enzyme Indicators: A Complementary Approach 7/27/2026

    Quantitative enzyme indicators complement biological indicators to deliver rapid, site-specific lethality data for VPHP decontamination validation.

  3. Future-Focused Customer-Centric Bioprocessing Solutions With Eppendorf 7/24/2026

    De-risk bioprocess scale-up with application-focused workflow validation. Discover strategies for transitioning therapies from R&D to clinical production.

  4. Beyond Flexibility: The Strategic Value Of Single-Use In Virus Filtration 7/24/2026

    Single-use virus filtration offers key strategic benefits beyond operational convenience, enabling faster time to market, scalable manufacturing, and flexible supply chains for biopharma production.

  5. Navigating AI Compliance In Life Sciences: FDA Policy Insights For AI Governance 7/22/2026

    Navigating life sciences AI compliance requires strong governance, expert human oversight, and transparent, low-risk deployment strategies.

  6. Quality Equipment Design Proven Through Testing 7/20/2026

    Rigorous multi-cycle stress testing and environmental validation ensure manufacturing hardware delivers uncompromising reliability for critical processing workflows.

  7. Starting With The End In Mind 7/16/2026

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

  8. Factory Acceptance Testing (FAT): Pre-Shipment Quality Verification Guide 7/6/2026

    Quality control begins long before installation. Discover how pre-shipment testing mitigates risk, ensures specification compliance, and streamlines cleanroom project timelines.

  9. 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.

  10. 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.