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Study of monoclonal antibodies at high concentration using the BioSAXS-2000

AppNote BX006 Researching monoclonal antibody drug formulations with the BioSAXS

Background

Monoclonal antibody drug formulations have to be stable at high concentrations (≥ 100 mg/mL) to achieve the low volumes required for subcutaneous delivery. Therefore, the development process to achieve such a preparation of antibody must include a regimen of thorough biophysical characterization while altering common formulation variables (e.g., pH, ionic strength, buffering agent, etc.). Since many biophysical techniques require sample dilution prior to measurement, the characterization may not accurately predict antibody behavior at high concentrations. Small angle X-ray scattering is well-suited to measuring antibodies, and macromolecules in general, at both low and high concentrations, and in the exact conditions of the formulation. Here, we analyzed two recombinant immunoglobulin G (IgG) variants at a range of concentrations with the BioSAXS-2000 to quickly characterize their solution behavior.

SAXS products from Rigaku

Small angle X-ray scattering (SAXS) Kratky camera system

Small and wide angle X-ray scattering instrument designed for nano-structure analyses

Small and wide angle X-ray scattering instrument designed for nano-structure analyses

A modernized 2D Kratky system that eliminates data corrections required of traditional systems

Special CMF optic designed for SAXS instrumentation

Multipurpose products from Rigaku

Single crystal X-ray diffractometer with custom enclosure and flexibility for easy integration of accessory components

Advanced state-of-the-art high-resolution XRD system powered by Guidance expert system software

Highly versatile multipurpose X-ray diffractometer with built-in intelligent guidance

High-performance, multi-purpose XRD system for applications ranging from R&D to quality control