Featured Articles

  1. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.

  2. 4031 Ready Methods Reduce E&L Timelines

    An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

  3. Successful Industrialization Requires Solid Foundations

    Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

  4. Design Success Combined With Expertise In Testing And Raw Material Selection

    Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

  5. Key Considerations For Packaging Solutions For Cell And Gene Therapies

    Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.