Featured Articles
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Industry Trends In Biologic Formulations
Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.
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The Importance Of Strategic Alliance Partners In Biopharmaceuticals
Today’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.
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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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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.
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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.
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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.