ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Challenges And Opportunities Of Real-World Evidence: Part I

  Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

• Seven Softgel Myths: Are You Missing Your Softgel Opportunity?

  Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• Promising Early Results For New High-Performance DPI

  This report discusses the benefits of the αeolus technology, a passive, high-performance, high-consistency dry powder inhaler platform concept, and the preliminary performance data from early-stage development.

• 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.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

• Aseptic Filling And Processing Considerations For Biosimilars

  One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

• Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications

  A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.

• Overcoming Melt Processing Challenges

  Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

• 4 Most Common Reasons For Medical Device Material Failures

  Material failures in medical devices can have severe consequences for companies. By implementing a proactive design framework , companies can significantly reduce these risks and the associated costs.