Outsourced Pharma Editorial

  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. A Woman Relegated To The Manufacturing Night Shift 3/8/2026

    After graduating with a biology degree from Howard University and entering the pharma industry, Stephanie Wimberly found herself the only woman — the only black woman — in a manufacturing facility in Maryland. A supervisor made it clear he didn’t want her on his team; she was reassigned to the night shift at her facility. “I had a family to support, and night shift, or abuse, was not what I signed up for,” she says. “But I didn’t have many options.” Here is how she persevered, and prospered.

  7. 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.

  8. 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.

  9. A Biotech Business Model That's Investor-Friendly 3/2/2026

    For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

  10. The Supreme Court Rules On Trump Tariffs. Why Shout "Hooray!"? 2/28/2026

    Chief Editor Louis Garguilo says like many readers, he agrees with the "wise and narrow decision" by the U.S. Supreme Court that President Trump cannot use the International Emergency Economic Powers Act to impose sweeping tariffs. At the same time, for those who immediately threw up an instant “Hooray!” he suggests checking yourself on why such enthusiasm. His analysis on what is actually best for our global outsourcing industry.