Featured Articles

  1. Low Temperature Storage Containment For Vial And Syringe Systems 6/20/2025

    With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

  2. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

    All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

  3. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

  4. Fixtures And Surrogates For Combination Product Performance Testing 5/16/2025

    The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

  5. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

  6. Vial Adapter Considerations For Cell And Gene Therapy Applications 4/21/2025

    Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.

  7. FAQs On The Revised EU GMP Annex 1: Volume 2 3/5/2025

    Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

  8. FAQs On The Revised EU GMP Annex 1: Volume 1 3/5/2025

    The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

  9. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

  10. Achieving EU GMP Annex 1 Compliance For Contamination Control 3/4/2025

    Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.