Stability of the novel recombinant human albumins Albucult® and Recombumin® demonstrated by light scattering techniques

In a recently published article, researchers from Novozymes Biopharma (Nottingham, UK) and Malvern Panalytical (Malvern Panalytical, UK) describe collaborative work using light scattering techniques to demonstrate the short- and long-term stability of the novel recombinant human albumins Albucult® and Recombumin®. These rAlbumins have been developed and optimized to deliver a safe, stable and regulatory-compliant product for therapeutic formulations. The teams applied the resolving and detection capabilities of size exclusion chromatography light scattering (SEC-LS) and dynamic light scattering (DLS) offered by Malvern Panalytical systems to monitor the stability of these Novozymes products. The article ‘Tools for evaluating the stability of human recombinant albumins used in human therapeutics’ can be accessed at https://www.malvernpanalytical.com/en/industries/biologics/biological-formulation-development

Novozymes Biopharma develops and manufactures high quality, animal-free and regulatory-compliant recombinant ingredients and technologies to support the development of innovative pharmaceutical products. Understanding and manipulating protein behaviour is a central element of the associated research and a core company expertise. The work described here focused on the use of light scattering techniques to test protein stability under a variety of conditions. Malvern Panalytical’s Zetasizer APS, Zetasizer Nano ZS and Viscotek TDAmax SEC-LS were used in studies that examined the effects of pH, temperature and concentration on oligomerization and aggregation behaviors. The results can be used to demonstrate short-term stability and predict shelf life.

Both SEC-LS and DLS were found to be useful for the rigorous testing required to understand and confirm protein stability under various conditions. SEC-LS allows detailed characterization of the type of oligomers or aggregates present in samples of therapeutic proteins. DLS provides a rapid measurement that allows rapid comparison of a number of sample conditions and to indicate the presence of large aggregates and small oligomers or aggregates.

Malvern Panalytical offers a growing range of systems for protein characterization. The Zetasizer Nano is one of the most widely applied systems for measuring particle size and molecular size using dynamic light scattering, and protein mobility (zeta potential) by electrophoretic light scattering, while the Zetasizer APS offers robust, simple to operate, dynamic and static light scattering and automates the measurement of samples in industry standard 96- or 384-well plates. The Viscotek TDAmax is a complete, research grade, temperature controlled, multi-detector SEC system suitable for the molecular weight and molecular size determination of proteins and other macromolecules. For more about Malvern Panalytical’s range of systems for protein characterization go to  https://www.malvernpanalytical.com/en

Novozymes' animal-free, recombinant albumin (rAlbumin) range helps pharmaceutical drug and medical device manufacturers deliver safe and affordable product improvements in a variety of applications. Further information can be found at: https://www.novozymes.com/en