Featured Editorial

  1. Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing 12/15/2025

    How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

  2. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  3. Avoiding Protein Purification Artifacts That Still Undermine Drug Design 12/15/2025

    Protein purification artifacts are common technical issues, but when they go unnoticed, they can distort structural data and later lead to unreliable experimental results.

  4. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

    MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

  5. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

    A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

  6. 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.

  7. TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration 12/8/2025

    When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

  8. 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.

  9. 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.

  10. 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.