Biosimilar Manufacturing solution center

  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. What To Do About Process Drift In Your Biosimilar's Reference Product 5/22/2026

    Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs.

  7. Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit 5/22/2026

    The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.

  8. Why Contamination Control By Design Should Matter To Your CDMO 5/18/2026

    EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

  9. A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight 5/18/2026

    A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

  10. 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.