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Analysis of Biopharmaceutical Lyophilizate Specific Surface Area by Mercury Intrusion Porosimetry (CAT#: STEM-B-0422-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

Mercury intrusion porosimetry (MIP) is a powerful technique utilized for the evaluation of porosity, pore size distribution, and pore volume (among others) to characterize a wide variety of solid and powder materials. The instrument, known as a porosimeter, employs a pressurized chamber to force mercury to intrude into the voids in a porous substrate. As pressure is applied, mercury fills the larger pores first. As pressure increases, the filling proceeds to smaller and smaller pores. Both the inter-particle pores (between the individual particles) and the intra-particle pores (within the particle itself) can be characterized using this technique.

Applications

Biopharmaceutica

Procedure

1. Place the sample to be evaluated in a suitable holder or container called a permeability meter.
2. The battery is installed in the pressure chamber inside the porosity meter, vacuumed and backfilled with mercury.
3. Collect data and calculate.

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Porosimeter