Biosimilar Insights

  1. Mild pH Protein A Purification Step With A Mild Elution Resin 5/22/2026

    As antibody formats diversify, low-pH protein A elution can drive aggregation and yield loss. Learn how milder elution conditions during capture can help protect sensitive molecules and ease challenges.

  2. Keeping mAb Aggregation Low During The Final UF/DF Step 5/22/2026

    mAb aggregation can arise from molecular properties, process conditions, and equipment‑driven stress. Learn where aggregation risk increases across downstream processing and formulation.

  3. Controlling mAb Aggregates In Chromatography Process Development 5/22/2026

    Antibody aggregation remains a critical downstream challenge, particularly for complex modalities. Explore why aggregates form, why they matter, and how chromatographic strategies can help reduce risk.

  4. Simulating PUPSIT Or Gas Purges In Bacterial Challenge Tests 5/22/2026

    Managing PUPSIT‑related risks is a critical part of contamination control. Learn how bacterial retention studies, wetting fluids, and downstream practices influence sterility assurance.

  5. Product-Wet Integrity Testing: Risk-Based Strategies 5/22/2026

    When standard water‑based integrity testing falls short, product‑wet approaches can offer a more representative alternative. Learn how risk‑based strategies are used to establish reliable test limits.

  6. In Vivo Manufacturing: When The Body Becomes The Bioreactor 5/15/2026

    Breakthrough therapies are reshaping medicine, but manufacturing complexity is holding them back. Discover how rethinking production and delivery could expand reach and improve patient experience.

  7. In Biosimilar Analytical Development, Is A CQA Ever Not Critical? 4/20/2026

    The word "critical" implies a binary signal. The attribute is either existentially important or it's not.

  8. Standards' Role In Biosimilarity Assessment 4/20/2026

    Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.

  9. The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval 4/20/2026

    The FDA's recent and stunning declaration that comparative analytical assessments (CAA) are generally more sensitive than clinical efficacy studies (CES) shows the great degree in which the agency is leaning on analytics rather than clinical data when considering 351(k) applications for biosimilars.

  10. The Necessity Of Potency Assay Matrices For Complex Proteins 4/20/2026

    For complex proteins, the FDA requires a matrix of orthogonal potency assays. Sponsors must assess all functional activities of a product, especially when the mechanism of action is known.