22. March 2016

The International Conference on Harmonization Q8 (R2) includes a requirement that “Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of the drug product,” that is, the need to assess the robustness of a formulation. In this article, a quality-by-design–based definition of a “robust formulation” for a biopharmaceutical product is proposed and illustrated with a case study....

06. January 2016

The structural and thermodynamic properties of glassy carbohydrate matrices for the encapsulation and biostabilization of sensitive bioactive compounds, such as pharmaceutically active proteins and oxidation-sensitive compounds, are reviewed in the context of the plasticization and antiplasticization of glassy carbohydrates of intermediate and high molecular weight by low molecular weight diluents. More

28. July 2015

This paper presents a multiobjective design method for determining the optimal setup of excipients use processes, e.g., material reception storage testing and actual usage considering quality and cost-effectiveness. More