Featured Articles

  1. Why Connect An Auto-Injector To A Smartphone?

    Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not? 

  2. 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.

  3. Best Practices For Ensuring Quality In Biologic Products

    New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. 

  4. Gaps In Reconstitution Process Filled By Water-For-Injection Syringe

    The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.

  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. 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.

  7. 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.

  8. 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.

  9. A Proactive Approach To Reducing Particulate Risk

    A biotech that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines.

  10. Trends In Prefillable Syringe Systems Concerning Volume And Viscosity

    The concentration and viscosity limits of protein-based drugs have historically limited the injection volume of biologics to around 1mL of drug in a prefillable syringe systems.