Industry Insights

  1. The Secret To True GMP-ness In The Cell & Gene Therapy Sector 5/2/2025

    Much of what we do in cell & gene therapy manufacturing is deeply habit-based. When employees understand the purpose behind a task, it supports their autonomy and competence.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.