Guest Columns

  1. Enzyme Activity As A Surrogate Potency Marker In Cell Therapy 8/26/2026

    When measuring cell therapy potency, biochemical assays can provide a rapid alternative to the time- and material-consuming standard of cell-based assays.

  2. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

  3. Choosing Analytical Technologies At The Right Stage Of Development 8/24/2026

    Take a beat before investing in the latest analytical tools. Capability and sensitivity come at a cost. Depending on your phase, you might not need it just yet.

  4. The Complex Anatomy Of An ADC Tech Transfer 8/20/2026

    Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

  5. What Goes Into Restarting A Shelved Orphan Drug Candidate? 8/19/2026

    The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

  6. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  7. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

  8. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  9. In Bioprocessing, Trusted Data Is A Process Variable 8/6/2026

    As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

  10. Combination Cell Therapy's Clinical Success Hinges On Manufacturability 8/5/2026

    Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.