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Analysis of Biopharmaceutical Lyophilizate Residual Moisture by Thermogravimetric analysis (TGA) Method (CAT#: STEM-B-0416-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

Thermogravimetric analysis (TGA) is a technique similar to LOD, but with the advantage of being able to use smaller sample volumes and improved control of weight and temperature. The sample is removed from the vial and weighed into an analytical tray in a low humidity glove box. The tray is sealed for transfer to a commercially available instrument consisting of a programmable oven and a microbalance. The weight of the sample is continuously monitored as the temperature is increased from ambient to a temperature that will repel water without degrading the sample.

Applications

Biopharmaceutica

Procedure

1. The sample is removed from the vial and weighed into an analytical tray in a low humidity glove box.
2. Continuously monitor the weight of the sample.
3. Record and calculate data.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Analysis pan, Programmable oven, MIcrobalance

Notes

TGA may be combined with other techniques such as mass spectrometry to differentiate which transitions are due to residual moisture and which are related to other volatiles.
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