Guest Columns

  1. Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity 3/27/2026

    Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.

  2. Ever Wonder What Running A $50B Capital Facilities Project Feels Like? 3/23/2026

    Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.

  3. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

    Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

  4. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

    Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

  5. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

    Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

  6. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

    Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

  7. FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address 3/17/2026

    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

  8. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  9. 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.

  10. 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.