Insights On Manufacturing Logistics

  1. Small Volume ATMP Cryo-Freezing Strategies 3/11/2025

    Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.

  2. Human Factors Testing: Engaging End-Users In Med Device Development 3/11/2025

    Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

  3. ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing 3/11/2025

    Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.

  4. 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.

  5. 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.

  6. Streamlining Compliance With Pre-Clinical Safety Tests 3/4/2025

    As cell therapies advance, challenges in ensuring safe, scalable, and compliant production increase. Discover how to develop efficient strategies to maintain cell viability and functionality throughout the supply chain.

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

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

  8. 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.

  9. Formulation Through Manufacturing Under One Roof 2/18/2025

    Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.

  10. Supply Chain Corrective Action Report Checklist 2/7/2025

    Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.