Featured Articles

81. Create An Effective Risk Management Program

    Drug-device combination products are rapidly increasing in use, based on their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.

82. Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

    Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

83. Delivering Market Success For Pharma Partners From Concept To Patient

    The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.

84. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

85. 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.

86. 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.

87. 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.

88. The Path To Commercialization For Wearable Drug Delivery Devices

    Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

89. The Importance Of Strategic Alliance Partners

    Complex drug delivery systems require teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms for patient use. These alliance partners must ensure self-administered therapies are safe, easy to use, and effective. 

90. 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.