Guest Columns & From The Editor

  1. 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.

  2. Mitigating Challenges In Solid Tumor Delivery 4/3/2026

    CAR T-cell therapy is advancing in solid tumors by improving target selection, trafficking, tumor-microenvironment resistance, and long-term function, but major biological barriers still require combined solutions.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Ensuring Quality Of CGT Materials 3/24/2026

    Here's why strong material selection, risk-based controls, and early analytics are critical for successful CGT development.

  8. Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials 3/24/2026

    Zymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.

  9. 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.

  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.