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. 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.

  3. The Key To Accelerating RNA-LNP Drug Development 12/27/2023

    Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.

  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. 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.

  7. 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.

  8. Revolutionizing Drug Discovery From "Undruggables" To AI 6/10/2024

    Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

  9. 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.