Clinical Supply Packaging Resources

  1. Is Your Clinical Supply Strategy Ready For EU CTR? 3/3/2022

    One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

  2. The 10 Most Frequently Asked Questions On Glass: Part 2 2/20/2024

    Read the second part of this series on the most common questions encountered by an expert focused in scientific affairs and technical solutions for glass.

  3. Winning The Race To FPI With Early Randomization And Trial Supply Management 9/8/2022

    Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. 

  4. Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials 5/24/2024

    The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.

  5. Planning Your Packaging For A Seamless Transition From Clinic To Launch 7/19/2022

    Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.

  6. Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage 3/24/2023

    Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

  7. Prefillable Syringe Plungers: A Solution For Low Temperature Storage

    Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

  8. Faster From Formulation To Fill/Finish 7/12/2022

    Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

  9. GxP Inventory Solution Improves Clinical IP Efficiency And Compliance 8/8/2023

    Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.