The Crystalomics® Department at Ajinomoto Althea CMO uses crystallized biotherapeutics to develop high concentration, low viscosity injectable drug formulations exceeding 200 mg/mL. The first step in our technology is to discover and develop crystallization conditions as rapidly as possible in order to meet short development timelines.

Crystallization of proteins, especially monoclonal antibodies (mAbs), is very challenging and typically employs extensive trialanderror. Incorporating highthroughput dynamic light scattering (HTDLS) into our precrystallization screening to characterize the protein in multiple buffers, we are able to significantly reduce the extent of crystallization trials. Analysis of the mAbs by multiangle light scattering coupled to sizeexclusion chromatography (SECMALS) as well as HTDLS is critical to determining optimal crystallization conditions with minimal time and effort.