Online Purification Monitoring for Real-Time Biologic Quality Release
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Solution Overview
Problem
Current methods for monitoring the concentration, purity, and potency of biological products during downstream processing are limited by the need for offline analysis, which introduces time lags and is not suitable for real-time release, especially in fast biopharmaceutical manufacturing processes.
Innovation Solution
Implementing a computer-based method that uses multiple online sensors for real-time monitoring and control, employing multivariate statistical analysis to predict and diagnose concentration, purity, and potency of biological products, allowing for process optimization and parametric or real-time release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If offline analysis methods are used to monitor concentration, purity, and potency of biological products, then measurement accuracy is maintained, but time lags are introduced that prevent real-time release
Solution Approach 1:
The patent replaces offline mechanical/chemical analysis methods with online sensors and multivariate statistical analysis systems. Sensors continuously monitor process parameters and feed data to computational models that predict product quality attributes in real-time, eliminating the need for time-consuming offline laboratory analysis while maintaining measurement accuracy through validated predictive algorithms
Solution Approach 2:
The patent introduces multivariate statistical analysis models as intermediaries between process parameters and product quality attributes. These models process sensor data and provide real-time predictions of concentration, purity, and potency, serving as a bridge that enables real-time release decisions without direct offline measurement
2Productivity
If multiple online sensors and multivariate statistical analysis are implemented for real-time monitoring, then real-time release capability is achieved, but device complexity increases
Solution Approach 1:
The patent creates a multi-functional integrated system where online sensors simultaneously monitor multiple process parameters (pH, conductivity, optical properties, temperature), the multivariate statistical analysis model concurrently predicts multiple product quality attributes (concentration, purity, potency), and the system supports both real-time process control and real-time release functions through a unified platform
Solution Approach 2:
The patent merges sensor data acquisition, multivariate statistical analysis, process control, and quality release decision-making into an integrated real-time monitoring system. This consolidation reduces operational complexity by providing a unified interface and workflow despite the sophisticated underlying technology
Data Source
AI summary
The invention relates to a method and device which allows in real-time the determination of concentration, purity and potency of a biological product during purification and/or concentration processes in order to intervene into the process, either for process control or real time release. The properties of the process stream are continuously monitored by at least two online sensors and with the aid of multivariate statistical analysis so that concentration, purity and potency is determined in real time.