Biosimilar White Papers

  1. Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization 8/25/2023

    There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

  2. Establishing Commercial Manufacturing Services For ADCs 6/3/2024

    Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

  3. Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass 5/12/2023

    Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.

  4. 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.

  5. Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators 4/28/2025

    Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

  6. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  7. 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.

  8. COGs Process Economics For Autologous Cell Therapy 8/11/2023

    Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.

  9. Business Continuity Management: The Benzonase® Endonuclease Success Story 8/21/2024

    Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.

  10. 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.