Biosimilar Manufacturing solution center

  1. High-Performing Ionizable Lipids For Controlled Nucleic Acid Delivery 9/29/2026

    Ionizable lipids are central to effective mRNA delivery, influencing potency, biodistribution, and toxicity. See why advancing delivery beyond the liver will require stronger structure-function insights.

  2. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  3. Transforming Gene Therapy With A Scalable Platform Solution 9/15/2026

    Discover how a platform approach to AAV manufacturing can reduce development time and cost, as well as how optimized processes enable reliable production and scalable implementation in bioreactors.

  4. 6 Modeling Approaches That Make Complex Bioprocess Data Useful 9/14/2026

    AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.

  5. Chromatography Polishing Under Pressure: New Demands 9/11/2026

    Upstream productivity gains and evolving antibody formats are raising the bar for chromatography polishing, making it a more consequential variable in downstream process design.

  6. Reliability In Bioprocessing Is Your Competitive Advantage 9/11/2026

    Equipment reliability is a prerequisite for realizing value from digital transformation, automation, and data-driven initiatives in bioprocess manufacturing.

  7. Building Trust In AI For Computerized System Validation 9/4/2026

    Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

  8. Controls For Retrieval-Augmented Generation In GxP 9/1/2026

    Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.

  9. Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins 8/27/2026

    Protein A chromatography intensification can increase productivity, but it may also affect process robustness. Explore key tradeoffs, operational challenges, and practical considerations.

  10. Optimize Process Performance And Maximize HCP Removal 8/27/2026

    Compare filtration strategies and explore how filter selection affects host cell protein removal, processing efficiency, and the balance between impurity clearance and filtration performance.