Featured Articles
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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.
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Selecting Container Closure Components: A Data-Driven Approach To CCI
Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.
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Prefillable Syringe Plungers: A Solution For Low Temperature Storage
Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.
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Plan For Your Extractables And Leachables Studies To Meet Submission Timelines
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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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.
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USP <382>: Think Systems, Not Components
This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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Addressing Glass Particulates In Injectable Drug Formulations
Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.
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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.
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Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs
Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
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Key Considerations For Selecting Flexible Fillers
Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.