Guest Columns

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Mind The Potent Compounds When Retrofitting Facilities For ADCs 1/12/2026

   Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.

10. New USP Research Shows MAM As Alternative To Conventional Methods 1/9/2026

    Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.