ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 5 Ways To Get Ready For IRT Regulatory Inspections

  Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

• Transforming The Pharma Supply Chain

  Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.

• Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions

  Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.

• Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization

  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.

• Is Your Clinical Supply Strategy Ready For EU CTR?

  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? 

• Controlled Substances In Clinical Trials

  Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.

• Vial Containment Systems For Gene And Cell Therapies

  CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.

• A Custom IRT System Facilitates Precision Medicine Studies

  As the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.

• Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials

  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.

• What Does 2025 Hold For Pharma?

  Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.