Meet Inspiring Speakers and Experts at our 3000+ Global Conference Series Events with over 1000+ Conferences, 1000+ Symposiums
and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business.

Explore and learn more about Conference Series : World's leading Event Organizer

Back

Mitra Mosharraf

Mitra Mosharraf

HTD Biosystems, USA

Title: Prediction and prevention of protein aggregation in multi-dose products

Biography

Biography: Mitra Mosharraf

Abstract

One of the major challenges in development of biotherapeutics is protein aggregation. Proteins tend to aggregate in solutions. These aggregates are often more immunogenic and less bioactive. Protein aggregation affects the quality attributes of the drug and has to be prevented throughout the shelf-life of the product. There are different mechanisms behind protein aggregation and appropriate formulation strategies can be employed to address this issue. Multi-dose formulations containing biotherapeutics often use phenolic compounds to ensure sterility. However, these preservatives are known to destabilize the protein and may cause aggregation. In this presentation, the interaction between phenolic preservatives and proteins was investigated using isothermal calorimetry in a TAM instrument in the presence and absence of different stabilizers . The effect of different additives on the enthalpy of binding of phenol to protein was evaluated. and thereby phenol induced aggregation of protein could be predicted. The initial aggregation of the protein in the presence of phenol was studied by size exclusion chromatography in the absence and presence of stabilizers. It was shown that aggregation was prevented using the found excipients, as predicted by this novel strategy.