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Analysis of Biopharmaceutical Lyophilizate Specific Surface Area by Micromeritics' TriStar II (CAT#: STEM-B-0423-CJ)

Introduction

The development of a lyophilized formulation and the corresponding freeze-drying process go hand in hand. An in-depth characterization of the freeze-dried powder during process development provides all relevant data require to optimize critical process parameters. Freeze-drying has advanced to the point where it is a common practice for biopharmaceuticals, including blood plasma and vaccines. Lyophilization is still a method of choice for preservation of the growing list of biopharmaceutical products.




Principle

Micromeritics TriStar II Plus provides fully automated surface area and porosity measurements on solid materials by using the technique of gas adsorption. This easy-to-operate, tabletop instrument is designed to analyse up to three samples simultaneously for optimum throughput.

Applications

Biopharmaceutica

Procedure

1. Sample preparation.
2. Place samples according to the instruction manual and set up experiments.
3. Download MicroActive software to analyze data and obtain reports.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Micromeritics' TriStar II

Notes

Surface areas as low as 0.01 m2/g can be measured with the standard nitrogen system. A krypton option can extend surface area measurements to as low as 0.001 m2/g.