Clinical Supply Packaging Resources
-
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.
-
IMP Labeling: EU CTR Transition Considerations
6/26/2023
Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
-
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.
-
Expertise And Transparency Drive A Distinct Development Journey
1/26/2026
Coordinated expertise, real‑time visibility, and clear communication support smoother development, manufacturing, and clinical supply. Strong alignment improves predictability and lowers risk.
-
Key Considerations For Emerging Companies When Selecting Packaging Components
Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
-
Optimized Laboratory Kitting Is Key To Successful Clinical Trials
5/18/2022
Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.
-
The Dual Sourcing Approach
11/17/2022
Having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.
-
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.
-
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.
-
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.