Analysis of Biopharmaceutical Lyophilizate Reconstitution Time and Behavior by Freeze-Drying Microscopy (FDM) (CAT#: STEM-B-0419-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.

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Principle Applications Procedure Materials Notes Related Products

Principle

FDM works somewhat like a miniature freeze-dryer. The sample is frozen inside a small microscope chamber by using liquid nitrogen. While applying a vacuum, the temperature is gradually increased and the sample dries. During this temperature ramp, the sublimation front is observed and recorded through a microscope. Changes in the dried layer can be used to determine the state of the system (amorphous or crystalline) and the collapse temperature of the sample.

Applications

Biopharmaceutica

Procedure

1. Sample preparation.
2. The sample is frozen inside a small microscope chamber by using liquid nitrogen. While applying a vacuum, the temperature is gradually increased and the sample dries.
3. During this temperature ramp, the sublimation front is observed and recorded through a microscope.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Freeze-drying Microscopy (FDM)

Notes

FDM is mainly employed during lyophilization process development and formulation development, where it is combined with differential scanning calorimetry (DSC) to determine optimal freeze-drying conditions.

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