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Application of First Principles Primary Drying Model to Lyophilization Process Design and Transfer: Case Studies From

Serguei Tchessalov¹, David Latshaw², Suresh Nulu³

¹Pfizer Inc, Bio Therapeutic R&D, Andover, MA, USA.

Journal of Pharmaceutical Sciences

|November 28, 2020

Summary

Lyophilization modeling is now accessible for pharmaceutical manufacturing. An Excel-based tool and case studies demonstrate practical applications and business benefits for primary drying phase modeling.

Keywords:

Freeze-drying Lyophilization Mathematical model(s)Mechanistic modeling Quality by design (QBD)Simulation(s)

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Area of Science:

Pharmaceutical Manufacturing
Chemical Engineering
Process Development

Background:

Lyophilization modeling is extensively documented academically but underutilized in pharmaceutical manufacturing.
A gap exists in practical, industry-friendly tools for implementing lyophilization modeling.
The BioPhorum Lyophilization Workstream identified the need for broader adoption.

Purpose of the Study:

To provide an accessible Excel-based tool for lyophilization modeling.
To introduce practical examples for modeling the primary drying phase.
To accelerate the adoption of lyophilization modeling in the pharmaceutical industry.

Main Methods:

Development of an ExcelTM-based tool for lyophilization modeling.
Inclusion of practical examples and case studies for the primary drying phase.
Demonstration of the tool's application during process development and scale-up.

Main Results:

An accessible tool is provided, facilitating the introduction to lyophilization modeling.
Case studies illustrate the successful application of the model in process development and scale-up.
The tool highlights tangible business benefits realized through its implementation.

Conclusions:

The developed tool and presented case studies lower the barrier for pharmaceutical companies to adopt lyophilization modeling.
Wider implementation of lyophilization modeling can lead to improved process development and scale-up.
Sharing collective knowledge through practical tools accelerates industry best practices.