FEATURED ARTICLES

• Keeping mAb Aggregation Low During The Final UF/DF Step

  mAb aggregation can arise from molecular properties, process conditions, and equipment‑driven stress. Learn where aggregation risk increases across downstream processing and formulation.

• Simulating PUPSIT Or Gas Purges In Bacterial Challenge Tests

  Managing PUPSIT‑related risks is a critical part of contamination control. Learn how bacterial retention studies, wetting fluids, and downstream practices influence sterility assurance.

• Product-Wet Integrity Testing: Risk-Based Strategies

  When standard water‑based integrity testing falls short, product‑wet approaches can offer a more representative alternative. Learn how risk‑based strategies are used to establish reliable test limits.

• In Vivo Manufacturing: When The Body Becomes The Bioreactor

  Breakthrough therapies are reshaping medicine, but manufacturing complexity is holding them back. Discover how rethinking production and delivery could expand reach and improve patient experience.

• ADC Development Grows More Complex — SPR Insights Bring Clarity

  Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.

• FDA's New Flexible CMC Framework For CGT

  The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

• Six Habits For Lab Equipment Maintenance

  Examine six practical habits that help labs protect equipment performance, prevent avoidable downtime, and strengthen daily workflows, from routine cleaning to IT partnership and scheduled service.

• Best Practices To Increase Reliability And Resilience

  Strengthen your biomanufacturing reliability with five essential habits focused on preventive care, skilled operators, smart spare‑parts planning, proactive maintenance, and expert support.

• Can Collaboration Close Biopharma's Talent Gap For Good?

  Biopharma innovation is accelerating, but workforce shortages threaten progress. See how strengthening collaboration is essential to developing the skills needed for emerging therapies.

• If Collaboration Fuels Biopharma Innovation, Why Can't We Connect More?

  Breakthroughs thrive when biopharma teams work across silos, yet collaboration remains surprisingly difficult. Explore the barriers and why they persist. What will it take to move beyond them?