Guest Columns

  1. What Procurement Should Evaluate In A Fill/Finish CDMO RFP 4/13/2026

    A framework for evaluating fill/finish CDMO RFPs beyond price and capacity, helping procurement teams uncover hidden costs, assess risk, and select partners built for scale.

  2. Mastering Biotech's Insourcing/Outsourcing Trade-Offs 4/10/2026

    Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.

  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. 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.

  5. 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.

  6. The Systems And Choreography Needed For Grade B ATMP Material Transfer 3/31/2026

    Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

  7. Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign 3/27/2026

    The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

  8. 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.

  9. Navigating GMP Biosafety Challenges In ATMP Manufacturing 3/26/2026

    BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.

  10. 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.