OP White Papers - random

  1. Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs 10/16/2024

    Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.

  2. Biologics Technology Transfer Guidebook 2/26/2025

    Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.

  3. 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.

  4. Overload Setting – Tricks And Techniques 9/23/2024

    Learn how a partner company that is committed to assisting manufacturers with calibration and optimal set-point establishment can serve as a valuable resource in achieving optimal tablet production.

  5. Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability 10/16/2024

    Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.

  6. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  7. Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes 4/8/2025

    The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

  8. Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection 10/3/2024

    Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

  9. Project Management: Sphere Of Influence 10/21/2024

    The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.

  10. The Benefits Of Incorporating Lean Methodologies Into Project Management 8/20/2024

    Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.