Aggregates Sizer Enables Evaluation of Biopharmaceutical Additives to Inhibit Protein Aggregation

Introduction

When performing formulation studies for biopharmaceuticals, investigation into the conditions for inhibiting aggregate formation is required because it is known that aggregate formation in biopharmaceuticals can cause serious side effects in the human body such as anaphylaxis. Solution composition is one such condition, yet it in itself comprises a wide range of conditions which require investigation because protein stability depends on combinations of pH, additive types, and concentrations. Therefore, evaluation that can be performed in a short time is desirable when evaluating stability. The Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals (referred to as Aggregates Sizer hereafter) is useful for improving efficiency of formulation studies because a large number of analytes can be processed in the time taken to perform a single measurement, which is only a few seconds. We here introduce a study in which we confirmed the differences in the ability of each additive to inhibit protein aggregation, by using Aggregates Sizer to measure the concentrations of aggregate formation in protein solutions containing different additives that have repeatedly been frozen and thawed.

March 9, 2017 GMT