Bioprocessing White Papers

  1. Developing Effective Procedures 10/21/2024

    Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

  2. 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.

  3. Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility 10/16/2024

    The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

  4. Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products 10/16/2024

    Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

  5. Setting The Standard For Plasmid DNA Production 10/16/2024

    Discover how Boehringer Ingelheim’s expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.

  6. Vial Fogging: Practical Considerations For Vial Selection 10/16/2024

    Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

  7. Oligonucleotide Synthesis: Scale-Up Made Simple 10/16/2024

    Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

  8. 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.

  9. Support Of Scale-Up And Technical Transfer Through Understanding Equipment 10/16/2024

    See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

  10. Seasonal Vaccine Manufacturing 10/16/2024

    Explore how our contract manufacturing solutions can help you meet the growing demand for seasonal influenza vaccines efficiently and effectively.