Biosimilar White Papers

  1. 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.

  2. 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?

  3. 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.

  4. 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.

  5. A Scalable Single-Use Two-Step pDNA Purification Process 3/6/2024

    Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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, reliability, and innovation in bioprocessing workflows.