Analysis of Biopharmaceutical Lyophilizate Residual Moisture by Near Infrared Spectroscopy (NIR) (CAT#: STEM-B-0417-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

NIR spectroscopy is a method that makes use of the near-infrared region of the electromagnetic spectrum (from about 700 to 2500 nanometers). By measuring light scattered off of and through a sample, NIR reflectance spectra can be used to quickly determine a material’s properties without altering the sample. NIR converts measured data into actionable information to help optimize processes or improve research. Capable of examining irregular surfaces with the same ease as a carefully prepared sample, NIR is non-destructive, and requires little or no sample preparation. It can also be used to analyze multiple constituents in a single scan.

Applications

Biopharmaceutica

Procedure

1. Prepare the sample.
2. Place the sample into the Near-infrared (NIR) spectroscopy instrument.
3. Analyze the data.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Near Infrared Spectroscopy (NIR)

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