Biosimilar White Papers

  1. Reliability In Bioprocessing Is Your Competitive Advantage 9/11/2026

    Equipment reliability is a prerequisite for realizing value from digital transformation, automation, and data-driven initiatives in bioprocess manufacturing.

  2. 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.

  3. 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.

  4. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC 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. Is Sustainability The Key To Agile Biopharma Manufacturing? 3/18/2025

    In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

  7. 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.

  8. 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.

  9. Optimizing Safety Measures For rAAV Therapies 10/11/2024

    Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

  10. 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.