Biosimilar Manufacturing solution center

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Implementing And Optimizing Your eQMS 8/25/2026

   This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

10. Chromatography Equipment Maintenance In An Era Of Acceleration 8/19/2026

    As chromatography systems become more sophisticated, maintenance directly influences uptime. Learn why coordinated maintenance strategies are essential for supporting complex analytical work.