How a Top Biotech Achieved Right-First-Time Batches for Increased Process Robustness and Lower Cost

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The Problem

Facing the pressing challenge of reducing operational inefficiencies and costs, a world-leading pharma manufacturer was caught in the grips of an ultrafiltration process dilemma, where downstream recirculations were severely impacting the operational efficiency of their leading product. With the daunting task of managing data sprawled across multiple disparate systems such as Oracle, DeltaV, and GLIMS, the complexity of streamlining the ultrafiltration step became an overwhelming hurdle. With only half of all batches achieving the right-first-time concentration of the critical quality attribute, the many process step iterations and the scattered nature of essential data turned what should have been a straightforward procedure into time spent chasing data. This situation not only hampered productivity but also threatened the quality and consistency of the Client's flagship product.

The Solution

Addressing our Client's ultrafiltration challenge required a bold, innovative approach. We began by integrating all available data from the purification line into Aizon Unify, bringing disparate information into a unified, contextualized view. No more data chasing. This comprehensive integration was the first step toward transformative change, allowing us to employ AI to detect critical patterns and relationships within the data.

Utilizing a real-time principal component analysis algorithm, we zeroed in on the critical process parameters (CPPs) with the most significant impact on the target critical quality attributes (CQAs). The breakthrough came with the development of a real-time predictive model capable of pinpointing the optimal CPP set points. This model ensured that the CQA values fell within the target range on the first filter circulation, dramatically reducing the need for costly and time-consuming recirculations.

The Big Wins

The Aizon implementation marked a turning point. For the first time, every batch met the right-first-time criteria, signaling a 61% reduction in recirculations. This remarkable achievement not only streamlined the purification process but also reflected a significant improvement in process robustness and associated cost reductions.

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