Featured Articles
-
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.
-
Biopharmaceutical Company Selects West's NovaPure 1mL Long Plunger For First Commercial Drug Launch
A small biopharmaceutical company looking to launch their first drug was seeking recommendations for packaging solutions for one of their pre-clinical drugs. They needed an experienced supplier that fully understood the challenges of delivering a biologic drug to the market.
-
Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems
Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
-
Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C
This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.
-
How To Address Challenges In Oncology Drug Containment
Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
-
Industrialization And Scale-Up Of Drug Delivery System
A pharma company and its product design partner were in need of a contract manufacturer able to support its device development, injection molding, tooling, logistics, and scale-up automation strategy.
-
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.
-
NovaPure Stoppers - The Right Choice For Oncology Drugs
Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.
-
Have You Selected The Right Stopper For Your Lyophilized Drug Product?
Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.
-
Container Closure Integrity: A Risk-Based Approach
Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.