Featured Articles
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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.
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Overcoming Challenges In Cell And Gene Therapy Containment
Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
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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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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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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.