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Analysis of Biopharmaceutical Lyophilizate Appearance and Structural State by X-ray Powder Diffraction (XRD) (CAT#: STEM-B-0425-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

XRD is employed during lyophilization process development and supports results obtained from scanning electron microscopy, BET analysis and Karl-Fischer titration in defining optimal freeze-drying conditions.

Applications

Biopharmaceutica

Procedure

1. Obtain a few tenths of a gram (or more) of the material, as pure as possible.
2. Grind the sample to a fine powder, typically in a fluid to minimize inducing extra strain (surface energy) that can offset peak positions, and to randomize orientation. Powder less than ~10 μm(or 200-mesh) in size is preferred.
3. Place into a sample holder or onto the sample surface.
4. For unit cell determinations, a small amount of a standard with known peak positions (that do not interfere with the sample) can be added and used to correct peak positions.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: X-ray Powder Diffraction (XRD) Instrumentation