Alternate potency targeting system and method

The computer-implemented system addresses the inefficiencies in evaluating alternate potency targets by providing an automated workflow for data preprocessing and statistical modeling, thereby reducing the risk of OOS events and enhancing process capability in biologics manufacturing.

WO2025058983A1 Publication Date: 2025-03-20BAYER HEALTHCARE LLC
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Patent Information

Application Number
PCT/US2024/045832
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-11
Filing Date
2024-09-09
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

The existing methods for evaluating alternate potency targets in biologics manufacturing are time-consuming and inefficient due to manual workflows and limitations in commercial software, such as lack of customizability and accessibility.

Method used

A computer-implemented method and system that provides a front-end dashboard for user input and a backend for data preprocessing, statistical modeling, and outputting results, enabling efficient evaluation of alternate potency targets and displaying associated Out of Specification (OOS) risks.

Benefits of technology

The system streamlines the assessment of alternate potency targets, reducing the risk of Out of Specification (OOS) events, improving process capability, and facilitating timely decision-making in biologics manufacturing.

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Abstract

The present embodiments relate to alternate potency targeting manufacturing. Subject matter of the present embodiments provides computer-implemented methods, computer systems and computer-readable storage media for predicting the results of alternate potency targeting manufacturing methods.
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