Guest Columns

  1. How To Implement Post-Approval Changes On A Global Level 4/14/2026

    To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

  2. The Business Case For Continuous Manufacturing In Biologics 4/14/2026

    The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

  3. From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations 4/6/2026

    Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

  4. New Research: Co-Expression Could Make Plant-Based Systems Viable 4/2/2026

    By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.

  5. Quantifying Single-Use Waste Produced During mAb Manufacture 4/2/2026

    Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.

  6. From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations 4/1/2026

    The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

  7. 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.

  8. 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.

  9. 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.

  10. 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.