White Papers

  1. Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future 9/16/2025

    See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.

  2. Enabling Quality By Design 9/8/2025

    Outdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.

  3. Navigating The Complexities Of Pre-Filled Syringe Manufacturing 9/4/2025

    Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

  4. Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide 9/4/2025

    Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.

  5. Placing Drug Strategies On A Solid Foundation For Success 9/3/2025

    Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

  6. Aggregation In Antibody-Drug Conjugates: Causes And Mitigation 9/1/2025

    Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

  7. Project Orbis Drug Registration 2025 8/22/2025

    Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

  8. Unlock Oncology Success With A Comprehensive Commercialization Guide 8/22/2025

    Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.

  9. Time To Intensify: Taking mAb Manufacturing To The Next Level 8/19/2025

    Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.

  10. Building Excellence In Pharma Manufacturing Through Rigor 8/16/2025

    A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.