Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

    As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

  6. Stopper Functionality – Key Considerations

    When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.

  7. 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.

  8. Mitigating Particulate Risk In Injectables

    What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?

  9. Improving The Patient Experience Without Sacrificing Quality Of Care

    A platform expands patient access to SC delivery via a large-volume device that attaches to the patient. This gives the patient more freedom of movement at the infusion center or allows administration to occur at a different location.

  10. Key Considerations For Emerging Companies When Selecting Packaging Components

    Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.