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Analysis of Biopharmaceutical Lyophilizate Residual Moisture by Vapor Pro Moisture Analyzer (CAT#: STEM-B-0418-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

Moisture analysers utilise Loss On Drying (LOD) method to measure moisture. In this method, the moisture analyser weighs a sample, heats it up to dry it, and weighs it again once it's dry. The weight after drying is subtracted from the weight before, so the loss of moisture is determined using the loss of mass.

Applications

Biopharmaceutica

Procedure

1. Prepare the sample.
2. Weigh the sample for moisture determination and dry it by heating, then weigh it again after drying.
3. Calculate and record the data. Subtract the weight after drying from the weight before drying and use the mass loss to determine the moisture loss.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Vapor Pro Moisture Analyzer