Featured Articles

81. 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.

82. Comparing Vial Container Closure Systems

    Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.

83. Control Strategy Factors For Drug-Device Combination Products

    Building a control strategy comprises understanding the connectivity among materials of composition, components, constituent parts, final drug-device combination product, and critical process parameters.

84. Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

    As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

85. Testing For Parenteral Packaging And Delivery Systems

    There are many aspects to consider when developing a sound approach to performance testing to qualify packaging and delivery systems, and combination products.

86. Successful Industrialization Requires Solid Foundations

    Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

87. 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.

88. Improving The Patient Experience Without Sacrificing Quality Of Care

    A platform expands patient access to SC delivery via a large-volume device that attaches to the patient. This gives the patient more freedom of movement at the infusion center or allows administration to occur at a different location.

89. Why Connect An Auto-Injector To A Smartphone?

    Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not? 

90. 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.