Injectable Drug Delivery Resources

1. Navigating Regulatory Challenges In Oligonucleotide Therapeutics 12/12/2024

   Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

2. Formulation Development For Injectables 6/13/2023

   A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.

3. Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk 1/18/2022

   Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

4. Optimizing Syringe Performance For Reliable Drug Delivery 4/21/2026

   Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

5. Sterile Injectable Therapies: Revolutionizing Lifecycle Management

   The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

6. Enabling Subcutaneous Delivery For Improved Patient Compliance 3/3/2025

   The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.

7. Prioritize Safety And Mitigate Risk In HPAPI Manufacturing

   As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

8. Formulation Development From Preclinical To First-In-Human 1/24/2022

   A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

9. De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions: BD Vystra™ Disposable Pen For Semaglutide 6/26/2025

   The BD Vystra™ Disposable Pen for Semaglutide is a generic drug-device combination, designed for usability and regulatory compliance, showing comparable performance to the reference device.

10. How Oral GLP-1 Therapies Are Revolutionizing Obesity Treatment 2/3/2025

    The rising incidence and severity of obesity have amplified a therapeutic need in healthcare. Read more about Dr. Srinivasan Shanmugam discussing the challenges and impact of GLP-1 analogs.