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Analysis the Glass TransitionTemperature of the Freeze-died Amorphous Product (Tg) by Differential Scanning Calorimetry (DSC) (CAT#: STEM-B-0420-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

During DSC analysis, the sample is exposed to a positive or negative temperature ramp, where thermal energy events are recorded in correlation to a reference sample (e.g., formulation buffer). In the context of lyophilization process development, DSC is an important and frequently used technique for the determination of the glass transition temperature of the maximally freeze concentrated solute (Tg’). This value is important to optimize primary drying conditions. The glass transition temperature of the freeze-died amorphous product (Tg) can also be determined by DSC and is used to define storage conditions for the final drug product.

Applications

Biopharmaceutica

Procedure

1. Preliminaries.
2. Turn on the Cooling Unit.
3. Weigh Out the Sample.
4. Crimp the Sample.
5. Load the Sample Into the DSC Machine.
6. Prepare the Program.
7. Set Up DSC Machine.
8. Start the Analysis."

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Differential Scanning Calorimetry (DSC)

Notes

DSC is a standard technique during lyophilization process development and formulation development, where it is frequently combined with freeze-drying microscopy [FDM].
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