New Feature: 'QbD Process Development Function' Added to Epistra Accelerate

Simultaneously Understand Robust Conditions and Design Space

The QbD Process Development function addresses the following challenges in production condition determination:

• Challenge 1: “Performance becomes unstable due to slight experimental variability or scale-up changes, leading to poor reproducibility”
• Challenge 2: “Determining acceptable ranges and design space requires significant time and resources”

These challenges caused delays and cost increases when condition revisions were needed during later development phases.

Streamlining the Research Timeline

The new function optimizes both condition exploration and design space estimation, significantly shortening development timelines.

Case Study: Joint Research with Astellas Pharma

Joint research with Astellas Pharma achieved “50- to 100-fold efficiency improvement” and design space estimation. The results were presented at the 24th Annual Meeting of the Japanese Society for Regenerative Medicine, demonstrating the integration of AI and robotics in automating stem cell culture processes. Key achievements include a “50- to 100-fold increase in NK cell yield” and successful design space estimation in just three experiments.

Two Solution Approaches

Robust Optimization

AI identifies conditions that maintain stable quality even with parameter variations. “Robust conditions” are automatically derived from optimization data.

Design Space Visualization

Acceptable parameter ranges are displayed as contour plots, enabling practical Quality by Design implementation with fewer experiments than conventional approaches.