Articles, App Notes, Case Studies, & White Papers

  1. Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics 5/9/2024

    Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

  2. From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

    Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

  3. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  4. 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.

  5. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

    All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

  6. Zero-Stress Low Volume Aseptic Filling For Solids And Liquids 6/26/2023

    Aseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.

  7. New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology 3/29/2023

    Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.

  8. Elastomer Plungers With Barrier Film For COVID-19 Vaccines

    Minimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.

  9. 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.

  10. Evaluating Biomanufacturing Possibilities To Meet Patient Needs

    When navigating uncertain demand forecasts or limited budgets, consider partnering with a CDMO that can accommodate multiple manufacturing strategies and diverse scenarios biologic sponsors face.