Expert Insights on GCT Cold Chain Logistics

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. 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. 

6. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

   Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

7. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

   AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

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. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

    The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.