Expert Insights on GCT Cold Chain Logistics

  1. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services 8/15/2024

    These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

  2. DSCSA Implementation Is Progressing, But More Complexity May Be Coming 8/5/2024

    The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.

  3. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

  4. Sorting Through Winners And Losers Of New Technology In Pharma 5/30/2024

    Innovation and improvement are often used synonymously, but sometimes innovation hinders more than helps. Here’s a cold-eyed look at recent blockbuster tech advances.

  5. Adapting Clinical Supply Strategies Through The Phases 5/17/2024

    Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.

  6. Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances 5/10/2024

    Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.

  7. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

    The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

  8. Managing Supply Chain Risks Using Relational Risk Analysis 4/5/2024

    In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.

  9. What Really Happens When A Cell Therapy Supply Chain Fails? 4/5/2024

    A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.

  10. Best Practices For Clinical Supply Chain Management In Rare Disease Trials 3/27/2024

    A supply chain pro discusses three of the greatest challenges in clinical trial supply management for rare diseases and strategies to overcome them.