Industry Insights

  1. 3D Organoids Lead The Way For Personalized Cancer Therapy 12/29/2021

    As an inherently molecular approach to cancer therapy, precision medicine relies entirely on matching up individualized responses with potential treatments — something organoids are uniquely suited to predict given their composition.

  2. Why The Right Partnerships Are Key To Harnessing New Sterile Delivery Methods 9/19/2024

    By leveraging the expertise of CDMOs, pharmaceutical firms can expedite their time to market, reduce costs, and improve patient outcomes, ultimately advancing the future of drug delivery methods.

  3. Decisions In A COVID-19 World: Combat Stress With Quality Risk Management 4/22/2020

    Few of us have ever lived with so much uncertainty and lack of knowledge as we are facing now. This article explains why a structured approach for making risk-based decisions is so important, particularly when we find ourselves in stressful conditions with conflicting needs on many fronts.

     

  4. Risk Management Processes For Cell And Gene Therapies 7/9/2024

    Delve into several considerations of risk and knowledge management in the cell and gene therapy environment, providing essential insights for effective product development.

  5. The Modular Advantage: Stick Built vs. Modular

    There are three major options when building a pharmaceutical grade cleanroom on your existing site — stick built, modular, or podular. Here, modular installation and stick built construction are compared.

  6. Best Practices For Efficient Bioprocess Technology Transfer

    A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. 

  7. Why Manual QbD Leads To Delays, Errors, And Ongoing Frustrations 10/24/2025

    Manual QbD methods slow timelines and increase risk. Learn how intelligent, digital frameworks are helping CMC teams improve quality, accelerate submissions, and meet rising regulatory expectations.

  8. Friendshoring: A Strategic Shift In Pharma Supply Chains 4/11/2025

    To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

  9. How To Unlock Efficiency In MES Integrations 5/16/2024

    This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.

  10. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.