Featured Articles

  1. 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.

  2. 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?

  3. 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.

  4. 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.

  5. 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.

  6. Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems

    Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

  7. Selecting Container Closure Components: A Data-Driven Approach To CCI

    Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.

  8. FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III

    The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.

  9. 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.

  10. 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.