Featured Articles
-
Industry Trends In Biologic Formulations
Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.
-
Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems
Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
-
A Step Change In Pharmaceutical Glass Packaging Innovation
Valor Glass represents a significant, and much needed, step forward for glass innovation. Review the findings and learn how an aluminosilicate formulation can lower your glass vials' extractables profile.
-
Is It Ever Too Soon To Start Your Performance Testing Assessment?
Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.
-
Demystifying Performance Testing: Strategies To Qualify Combination Products
Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.
-
A Glass Package Designed Specifically for Pharmaceutical Use
A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.
-
The Importance Of A Human Centered Approach To Product Development
To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.
-
The Largest LOE Event In US Pharma History
Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
-
Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers
Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.
-
Your Approach To USP <382> For Your Drug Product Packaging
The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.