Guest Columns

  1. When Lyophilization Fails At Scale, First Scrutinize Your Formulation 10/16/2026

    When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

  2. The 5 Shifts That Could Remake Lyophilization By 2040 10/15/2026

    Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

  3. Your 7 Decisions To Make Before MES Configuration 10/7/2026

    Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

  4. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

    Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

  5. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

    By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

  6. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

    The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

  7. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  8. 6 Modeling Approaches That Make Complex Bioprocess Data Useful 9/14/2026

    AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.

  9. Building Trust In AI For Computerized System Validation 9/4/2026

    Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

  10. A Gentler Cell Line Selection Method Using microRNA 9/4/2026

    Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.