Clinical Supply Packaging Resources

1. 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.

2. 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.

3. 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? 

4. 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.

5. GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm 8/15/2023

   Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.

6. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

   A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

7. Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization 2/20/2024

   While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

8. Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change 3/9/2023

   A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

9. 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.

10. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.