Guest Columns & From The Editor

  1. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

    From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

  2. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.

  3. Designing The Next Wave Of T Cell Engagers 5/1/2025

    Abpro's associate director of biology has led programs in immuno-oncology R&D with a focus on therapeutic T cell engagers. We caught up with him to discuss how industry can pave a future for the field.

  4. Using Virtual Reality To Enhance Aseptic Contamination Control 5/1/2025

    Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

  5. AI Vs. Humans In Novel Drug Target Identification 4/30/2025

    Artificial intelligence is beginning to replace humans in drug discovery, one expert warns — but the industry isn’t ready for the shift.

  6. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  7. A Checklist For Mechanism-Based Potency Testing In Cell Therapy 4/25/2025

    New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.

  8. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

    Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

  9. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  10. Navigating CGT Biotech's Financial Headwinds And The Path Forward 4/24/2025

    Dr. Ali Pashazadeh, Founder of Treehill Partners shares how CGT companies can navigate today’s biotech downturn by embracing integrated strategies, disciplined capital use, and bold leadership willing to rethink traditional models across innovation, manufacturing, and commercialization.