Featured Articles

  1. 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?

  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. Biopharmaceutical Company Selects West's NovaPure 1mL Long Plunger For First Commercial Drug Launch

    A small biopharmaceutical company looking to launch their first drug was seeking recommendations for packaging solutions for one of their pre-clinical drugs. They needed an experienced supplier that fully understood the challenges of delivering a biologic drug to the market.

  4. 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.

  5. Early Decisions To De-Risk The Transition To Combination Products

    The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

  6. 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.

  7. Container Closure Integrity: A Risk-Based Approach

    Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

  8. 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.

  9. 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.

  10. How To Address Challenges In Oncology Drug Containment

    Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.