Characterizing protein aggregates by Nanoparticle tracking analysis (NTA) (CAT#: STEM-MB-0711-WXH)

Introduction

One of the major challenges in the development and production of biopharmaceuticals is to avoid aggregation of therapeutic proteins, which can be induced by different environmental stresses, including temperature, pH, freeze-thawing, light, shaking, metals, and even containers and closures. Protein aggregation can occur through one or more pathways, and protein aggregates can comprise native, structurally perturbed, covalently cross-linked or chemically modified components. The most important concern about protein aggregates is related to their potential immunogenicity, which has been evidenced in clinical settings and in vivo and in vitro studies.