Clinical Supply Packaging Resources

  1. Optimizing Storage & Distribution In An Era Of Clinical Trial Transformation 3/1/2023

    Explore the rapidly evolving complexities of clinical storage and distribution and how customized and patient-centric solutions have never been more paramount to support the healthcare of tomorrow.

  2. Clinical Supply Optimization: Process Improvement Accelerates Trials 6/3/2022

    A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

  3. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

  4. Faster From Formulation To Fill/Finish 7/12/2022

    Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

  5. Outsourcing Your Highly Potent Oncology Drug Product 4/6/2023

    Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.

  6. Gain Confidence In Clinical Trial Outcomes

    Delve into the ways that smart packaging integrations within clinical trial strategies can improve adherence to dosing protocols and provide a comprehensive understanding of a patient’s exposure.

  7. IMP Labeling: EU CTR Transition Considerations 6/26/2023

    Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

  8. Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization 2/20/2024

    While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

  9. Safeguarding Cell Therapy Cryopreservation: Primary Containers 5/20/2024

    Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.

  10. A Risk-Based Approach To Injectable Combination Product Development 3/14/2023

    Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.