Biosimilar White Papers

  1. 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.

  2. Performance Characteristics Of The Mobius® ADC Reactor For Conjugation 10/22/2024

    Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

  3. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  4. 2024 Global Biopharma Sustainability Review 9/3/2024

    What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

  5. The Advantages Of A Blended Learning Approach In Operator Training 5/30/2024

    Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.

  6. 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.

  7. Manufacturing Challenges With High Concentration Biologics 3/18/2024

    Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

  8. A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk 10/10/2024

    Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

  9. 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.

  10. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.