Featured Articles

  1. 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.

  2. 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. 

  3. 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.

  4. 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.

  5. Container Closure Integrity Evaluation For Cell And Gene Therapies

    With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

  6. 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?

  7. Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

    Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

  8. Prefillable Syringe Plungers: A Solution For Low Temperature Storage

    Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

  9. Extractables And Leachables – Assessing Risk In A Complex Landscape

    It is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.

  10. 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.