As more products are protein-based, the strategies for formulating these systems to ensure maximum stability still remains very much trial and error. However, new techniques are emerging that can provide information about two key aspects of ensuring maximum stability: 1) ensuring that the protein has not phase-separated from the stabilizing matrix; and 2) reducing the mobility of the matrix to reduce the propensity of the protein to aggregate. This topic is particularly relevant to the emerging biosimilars area, as two proteins may be identical in structure, but differences in formulation may lead to stability issues that are not related to the protein.
1:20 p.m. – 3:40 p.m., Nov 13, Room 23
AAPS Annual Meeting & Exposition
Analytical Methods for Predicting Protein Stability in Lyophilized Formulations
