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Application of circular dichroism and magnetic circular dichroism for assessing biopharmaceuticals formulations photo-stability and small ligands binding properties

DOI: 10.1016/j.ijpharm.2015.01.026 DOI Help
PMID: 25596417 PMID Help

Authors: Edoardo Longo (Diamond Light Source) , Rohanah Hussain (Diamond Light Source) , Giuliano Siligardi (Diamond Light Source)
Co-authored by industrial partner: Yes

Type: Journal Paper
Journal: International Journal Of Pharmaceutics , VOL 480 , PAGES 84 - 91

State: Published (Approved)
Published: March 2015
Diamond Proposal Number(s): 7559 , 8714 , 9786 , 10484

Open Access Open Access

Abstract: Synchrotron radiation circular dichroism (SRCD) is a powerful tool for photo-stability assessment of proteins. Recently our research has been interested in applying SRCD to develop screening methodologies for accelerated photo-stability assessment of monoclonal antibody formulations. Despite it was proven to be reliable and applicable within a wide range of salts and excipients containing solutions, the presence of far-UV (<260 nm) strong absorbing species (e.g., sodium chloride, histidine, arginine) in common formulations completely prevent the analysis. Herein, we propose a new method based on CD coupled with magnetic CD (MCD) to address the problem and offer an additional versatile tool for monitoring the photo-stability. This is done by assessing the stability of the samples by looking at the near-UV band, as well as giving insights in the denaturation mechanism. We applied this method to four mAbs formulations and correlated the results with dynamic light scattering data. Finally, we applied MCD in ligand interaction to key proteins such as lysozyme, comparing the human with the hen enzyme in the binding of N,N′,N′′-triacetylchitotriose.

Journal Keywords: Biopharmaceuticals; Drug development; Light stability assessment; Ligand binding; Magnetic circular dichroism; Circular dichroism

Subject Areas: Medicine, Technique Development, Biology and Bio-materials

Instruments: B23-Circular Dichroism

Other Facilities: No

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