Featured Articles

  1. 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.

  2. 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.

  3. The Path To Commercialization For Wearable Drug Delivery Devices

    Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

  4. Early Decisions To De-Risk The Transition To Combination Products

    The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

  5. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

  6. 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.

  7. Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

    Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

  8. Growing Complex Generic Application Load May Force US FDA Staffing Changes

    Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the coronavirus pandemic. Learn what forced the agency to lower hiring and retention expectations earlier this year.

  9. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

  10. Evaluation And Identification Of Subvisible Particulate Matter In Injections

    Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.