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. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

  4. Your Approach To USP <382> For Your Drug Product Packaging

    The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.

  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. Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers

    Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.

  8. USP <382>: Think Systems, Not Components

    This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

  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.