US 2026/0299524 A1Published application

Systems and methods for predictive control of lyophilization process

AssigneeTata Consultancy Services Limited

InventorsMayuresh Hiren MORE, Venkata Sudheendra BUDDHIRAJU, Venkataramana RUNKANA

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Abstract

For developing recipes for new products in the lyophilization system, extensive resource-consuming experiments need to be carried out. The parameters obtained through such experiments are often sub-optimal. Present disclosure provides a system and a method for predictive control of a lyophilization process by capturing the effect that freezing has on the product characteristics and consequently on the drying stages. The system utilizes real-time input from a lyophilization system, and the state estimation models to closely and predictively control the desired attributes of the product and determine optimal operating parameters for a desired product quality based on a comparison of the current state of the lyophilization system with a reference state. Image of the product is captured to identify defects in the vials, trace back to operating conditions and generate recommendations for defect mitigation.

Claims18

Dependent claims

A processor implemented method, comprising:

receiving, via one or more hardware processors, a set of process variables from a Lyophilization chamber, wherein the set of process variables comprises a shelf temperature, and a chamber pressure;
predicting, via the one or more hardware processors, a current state of the Lyophilization chamber based on the set of process variables using at least one prediction model), wherein the current state of the Lyophilization chamber comprises at least one of a temperature of a product in one or more vials, stresses due to lyophilization on proteins, a crystallinity of one or more excipients, an ice crystal size distribution, an ice content of the one or more vials, and a bound moisture content of the one or more vials;
performing, via the one or more hardware processors, a comparison of the current state of the Lyophilization chamber with a reference state );
generating, via the one or more hardware processors, one or more error signals based on the comparison and the current state;
and
predictively controlling, by using one or more models via the one or more hardware processors, the current state of the Lyophilization chamber through one or more control signals to attain a targeted state of the Lyophilization chamber and a set of state variables, based on the one or more error signals.

3 more elements

A system, comprising:

a memory storing instructions;
one or more communication interfaces;
and
one or more hardware processors coupled to the memory via the one or more communication interfaces, wherein the one or more hardware processors are configured by the instructions to:
receive a set of process variables from a Lyophilization chamber, wherein the set of process variables comprises a shelf temperature, and a chamber pressure;
predict a current state of the Lyophilization chamber based on the set of process variables using at least one prediction model, wherein the current state of the Lyophilization chamber comprises at least one of a temperature of a product in one or more vials, stresses due to lyophilization on proteins, a crystallinity of one or more excipients, an ice crystal size distribution, an ice content of the one or more vials, and a bound moisture content of the one or more vials;
perform a comparison of the current state of the Lyophilization chamber with a reference state;
generate one or more error signals based on the comparison and the current state;
and
predictively control, by using one or more models, the current state of the Lyophilization chamber through one or more control signals to attain a targeted state of the Lyophilization chamber and a set of state variables, based on the one or more error signals.

7 more elements

One or more non-transitory machine-readable information storage mediums comprising one or more instructions which when executed by one or more hardware processors cause:

receiving, a set of process variables from a Lyophilization chamber, wherein the set of process variables comprises a shelf temperature, and a chamber pressure;
predicting, a current state of the Lyophilization chamber based on the set of process variables using at least one prediction model), wherein the current state of the Lyophilization chamber comprises at least one of a temperature of a product in one or more vials, stresses due to lyophilization on proteins, a crystallinity of one or more excipients, an ice crystal size distribution, an ice content of the one or more vials, and a bound moisture content of the one or more vials;
performing, a comparison of the current state of the Lyophilization chamber with a reference state;
generating, one or more error signals based on the comparison and the current state;
and
predictively controlling, by using one or more, the current state of the Lyophilization chamber through one or more control signals to attain a targeted state of the Lyophilization chamber and a set of state variables, based on the one or more error signals.

3 more elements

Dependencies are inferred from the claim text.