Biosimilar White Papers

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Innovation In Filtration 3/18/2025

    Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

  7. The Evolution Of Antibody-Drug Manufacturing 6/3/2024

    Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.

  8. Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer 3/24/2025

    Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

  9. 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.

  10. 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?