Featured Articles
-
Successfully Navigating Opportunities With On-Body Delivery Systems
4/23/2026
Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.
-
Implementing Medium And High-Volume Drug Handling And Packaging Programs
4/23/2026
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
-
Safeguarding Biologic Integrity Through Enhanced Component Compatibility
4/21/2026
For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.
-
Optimizing Syringe Performance For Reliable Drug Delivery
4/21/2026
Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.
-
Maintaining Sterility Through Precise Component Design And Manufacture
4/21/2026
Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.
-
Robotics And AI In Pharma: Driving The Next Wave Of Innovation
2/23/2026
Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.
-
Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1
2/4/2026
Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.
-
FAQs On The Revised EU GMP Annex 1: Volume 7
2/4/2026
Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.
-
FAQs On The Revised EU GMP Annex 1: Volume 8
2/4/2026
Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.
-
Designing Robust Studies To Meet Auto-Injector Performance Requirements
10/30/2025
Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.