Micromeritics products for assessment of lyophilised biopharmaceutical compounds

Micromeritics’ TriStar II Surface Area Analyzer, AutoPore IV Mercury Porosimeter and AccuPyc II 1340 Gas Displacement Pycnometer are tools for determining the integrity of biopharmaceutical lyophilised cake. 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.

The structure of the cake, including density, total pore volume, pore size and surface area, needs to be tightly controlled in production. The three most commonly used characteristics to release or approve a batch are appearance, thermal properties and surface area. BET surface area, mercury intrusion porosimetry and gas pycnometry provide a more quantitative solution to visual inspection of the lyophilised cakes.