Mitra Mosharraf
HTD Biosystems Inc., USA
Title: Strategies to improve dissolution rate of lyophilized high dose protein formulations
Biography
Biography: Mitra Mosharraf
Abstract
There is an increasing interest in formulation development of lyophilized proteins and monoclonal antibodies at high concentration. Development of high dose protein formulations, is often associated with challenges such as slow dissolution of the lyophilized cake, poor syringeability, aggregation and thus poor stability after reconstitution. The latter becomes a major concern especially for the development of multi-dose formulations that may require several days of post-reconstitution stability, especially considering the protein preservative interactions. In this presentation the important parameters for improving dissolution of lyophilized protein cakes are discussed. Especial attention is paid towards dissolution of high dose protein formulations in dual chamber syringes, and strategies to improve dissolution rate of the lyophilized cakes in general.