OP White Papers - random

  1. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  2. Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing 6/13/2025

    Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

  3. Achieving Rapid, High-Titer Expression For Next-Generation Biologics 3/5/2025

    This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

  4. Stopper Migration In Frozen Pre-Filled Syringes 10/16/2024

    Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

  5. Designing A Disinfectant Study For Your Cleanroom 5/14/2024

    Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.

  6. Control Strategies And Method Development For Nitrosamines In APIs And Drug Products 4/15/2025

    Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

  7. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

  8. Considerations For Developing The Recirculation/Perfusion Process 6/6/2024

    Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.

  9. Enhancing Safety And Efficacy Of mRNA-Based Therapeutics 2/11/2025

    Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.

  10. Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical Supplies 5/5/2025

    Grasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.