Biosimilar White Papers

  1. 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.

  2. ADC Manufacturing: Practices, Challenges, And The Road Ahead 6/15/2026

    ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.

  3. Process Intensification And Other Ways To Adapt To Changing Needs 7/20/2026

    As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.

  4. Achieve Higher Targeted Concentrations 9/30/2025

    Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

  5. Why Biopharma Breakthroughs Aren't Moving The Market 10/20/2025

    Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

  6. Aggregation In Antibody-Drug Conjugates: Causes And Mitigation 9/1/2025

    Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

  7. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

    Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

  8. Aseptic Process Design And Simulation Under Annex 1 Guidelines 1/9/2026

    Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

  9. Perfusion Cell Line Development For Intensified Processes 5/5/2025

    The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.