Monitoring vial conditions during a lyophilization process

IL297904BActive Publication Date: 2026-08-01AMGEN INC
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Patent Information

Application Number
IL297904
Authority / Receiving Office
IL · IL
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-05-12
Filing Date
2021-05-11
Publication Date
2026-08-01
Estimated Expiration
2041-05-11

AI Technical Summary

Technical Problem

The lyophilization process for pharmaceutical drug products is challenging due to the inability to directly measure internal vial conditions like temperature and water content during commercial production, leading to potential product damage and increased manufacturing costs due to deviations in temperature and pressure control within the lyophilization chamber.

Method used

A scalable soft-sensor deployment framework for real-time monitoring of vial conditions during lyophilization, using external chamber temperature and pressure measurements applied to a mechanistic heat and mass transfer balance model to infer and predict in-vial conditions, allowing for manual or automated control adjustments without introducing sensors inside the vial.

Benefits of technology

This approach enables real-time monitoring and control of in-vial conditions, reducing waste and costs by accounting for temperature and pressure deviations, and potentially shortening the time required for commercial-scale recipe development by improving the agility and adaptability of the lyophilization process.

✦ Generated by Eureka AI based on patent content.

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Abstract

A method of facilitating real-time monitoring of conditions within a vial during a lyophilization process occurring within a lyophilization chamber includes, for each of a plurality of time intervals during the lyophilization process, determining current values of temperature and pressure within the lyophilization chamber and, after each time interval, determining current values of one or more conditions within the vial. Determining the current values of the condition(s) within the vial includes applying those current values as inputs to a heat and mass transfer balance model and solving for a current value of a temperature within the vial (and possibly water removed from or remaining within the product). The method also includes causing a display device to display the current value(s) of the condition(s) within the vial to a user, and / or controlling the temperature and / or pressure within the lyophilization chamber based on the current value(s) of the condition(s) within the vial.
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