Featured Articles
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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.
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Gamification: The Answer To Pharma’s Non-Adherence Crisis?
Digital connectivity is transforming the consumer experience and digital technology can now improve the patient experience too, in ways that were just not possible before.
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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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A Proactive Approach To Reducing Particulate Risk
A biotech that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines.
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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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The Importance Of An Analytical Testing Strategy
A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.
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Trends In Prefillable Syringe Systems Concerning Volume And Viscosity
The concentration and viscosity limits of protein-based drugs have historically limited the injection volume of biologics to around 1mL of drug in a prefillable syringe systems.
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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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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.