Biosimilar Manufacturing solution center

  1. The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process 6/2/2026

    Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.

  2. CDMO Selection: Start With The Relationship, Not The RFP 6/1/2026

    Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.

  3. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

    In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

  4. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

    This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

  5. Evaluating Antibody Fragment Purification Using VH3 Resin 5/22/2026

    Explore how VH-domain targeting enables efficient purification of VH3 antibody fragments and bispecific formats, with strong recoveries and flexible wash conditions that support improved purity.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.