Guest Columns

  1. This Industrial Fungus Has Protein Expression Promise For Pharma 2/12/2026

    Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.

  2. Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers 2/4/2026

    Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.

  3. High Specific Productivity For Leaner Sustainable Bioprocessing 1/30/2026

    Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

  4. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

    International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

  5. Facility Considerations When Retrofitting Legacy Sites For ADCs 1/26/2026

    Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

  6. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

    The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

  7. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

  8. Do's And Don'ts Of Material Handling When Retrofitting For ADCs 1/20/2026

    Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.

  9. Building Enterprise Resilience From QRM Signals 1/16/2026

    Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

  10. Single-Use Standards Are Maturing, But The Process Remains King 1/13/2026

    The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.