Guest Columns

  1. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  2. Trends In FDA FY 2025 Warning Letters 3/13/2026

    The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

  3. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

    Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

  4. Delivery Strategy For Next-Gen Cardiac Gene Therapies 3/12/2026

    As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.

  5. Accelerating Technology Diffusion In Cell And Gene Therapy 3/11/2026

    Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.

  6. 5 QMS Blind Spots You Should Know About 3/6/2026

    Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

  7. Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes 3/6/2026

    The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.

  8. Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE 2/27/2026

    By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.

  9. Green Supply Chains Rarely Start With A Pledge; Target Waste Instead 2/27/2026

    Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.

  10. The Real Reason We Haven't Fully Automated Cell Therapy Yet 2/26/2026

    Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.