GUEST COLUMNISTS

BIOSIMILAR WHITE PAPERS

  • 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.

  • 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?

  • 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.

  • 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.

  • 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.

BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

20_06_BSD_ComparativeEfficacy_Ebook_300x200

 

The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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