New range offers assessment of lyophilised biopharmaceutical compounds.
The range includes Micromeritics’ TriStar II Surface Area Analyser, AutoPore IV Mercury Porosimeter and AccuPyc II 1340 Gas Displacement Pycnometer.
The TriStar II is based on the well-established static gas adsorption technique.
It is a fully automated, three-station analyser designed to increase the speed and efficiency of quality control analyses with the accuracy, resolution, and data reduction features to meet most production and R&D requirements.
The TriStar II can provide the BET surface area data to help predict the effect of freeze-drying variations and enhance process control steps to prevent cake collapse.
Micromeritics’ AutoPore IV mercury porosimeter uses mercury intrusion and extrusion to determine total pore volume, pore size distribution, percent porosity, density, and compaction/compression.
The instrument collects extremely high-resolution data and can be equipped with two low-pressure stations and one high-pressure station or four low-pressure stations and two high-pressure stations for increased sample throughput.
The AccuPyc II is a gas displacement pycnometer that produces high-speed, high-precision volume measurements and density determinations of powders, solids, and slurries.
An increasing interest in lyophilised products
According to Micromeritics, there is an expanding emphasis on the area of lyophilised products in the pharmaceutical and biopharmaceutical industries.
Pharmaceutical companies are increasingly using lyophilisation technologies and production processes to produce a final dosage form that has a longer shelf life, enhanced stability, and fewer restrictions on transportation and storage.
It has recently been reported that 40% or more of pharmaceutical industry R&D and revenue now involves biopharmaceuticals.
Close to 60% of biopharmaceuticals (such as enzymes, proteins, and monoclonal antibodies) must be lyophilised as they are insufficiently stable for ready-to-use solution dosage forms.
Micromeritics’ TriStar II Surface Area Analyser, AutoPore IV Mercury Porosimeter, and AccuPyc II 1340 Gas Displacement Pycnometer are essential tools for determining the integrity of biopharmaceutical lyophilised cake.
Download the product brochures by clicking on the links above.
