Expert Insights On Cold Chain

  1. 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.

  2. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  3. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

  4. Why You Need A Raw Material Control Strategy 4/17/2025

    You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

  5. Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting 4/16/2025

    Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.

  6. Pharmaceutical Sovereignty: The Resilience We Cannot Outsource 4/15/2025

    Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

  7. How Is The Market Responding To Brisk HPAPI Demand? 3/17/2025

    The rise of precision medicine like ADCs has created new markets for highly potent API. More suppliers are building out capacity to meet the demand.

  8. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

    Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

  9. 4 Key Steps To Build Supply Chains For Later-Stage Clinical Trials In LMICs 3/6/2025

    Gates MRI's head of clinical supply discusses learnings and considerations that he keeps in mind for clinical trial supply chain/logistics.

  10. Distributed Cell Therapy Manufacturing Trade-Offs You Should Know About 3/5/2025

    For all its patient-centered benefits, producing personalized medicine at the point of care has pitfalls that are worth careful consideration.