Industry Insights

  1. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

    Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

  2. Navigating The Challenges Of Cell Therapy Clinical Trials 12/5/2025

    IN8bio CEO William Ho shares how they overcame operational challenges unique to cell therapy research, including how to carefully conduct site expansion and onboard new sites without disrupting study timelines.

  3. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

    Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

  4. Strained Manufacturing, Complexity Stymie In Vivo Progress 12/4/2025

     Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

  5. To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem 12/4/2025

    The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.

  6. Could Chicken Wisdom Help Cell Therapies Spread Wings? 12/2/2025

    Evolutionary theory could explain why cell therapies have hit a slump, and help developers get out of it, too.

  7. Formulation And Delivery Considerations For Cell And Gene Therapies 11/25/2025

    How can we ensure cell and gene therapies are truly transformative for patients? Success depends on the right combination of formulation, preparation, and delivery.

  8. The Promise And Paradox Of QbD 11/24/2025

    The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

  9. The Future Of Biotech Outsourcing: Essential Skills For Program Managers 11/24/2025

    The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.

  10. Rethinking The "3:1 Rule" In LNP Production 11/21/2025

    A new two-step, ideal-mixing strategy from MIT researchers shows how operating briefly in unstable regions of LNP assembly can unlock precise control of particle size and shape—advancing next-gen RNA manufacturing.