Formulation development supported by light scattering techniques

Researchers from Novozymes Biopharma and Malvern Instruments have been collaborating 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 optimised to deliver a safe, stable and regulatorycompliant 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 systems to monitor the stability of these Novozymes products.

The work is described in an article ‘Tools for evaluating the stability of human recombinant albumins used in human therapeutics’. See: www.malvern.com/formulationdevelopment

Novozymes Biopharma develops and manufactures high quality, animal-free and regulatorycompliant 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’s Zetasizer APS, Zetasizer Nano ZS and Viscotek TDAmax SEC-LS (Fig. 1) were used in studies that examined the effects of pH, temperature and concentration on oligomerisation and aggregation behaviours. The results can be used to demonstrate short-term stability and predict shelf life.

Fig. 1. Malvern Zetasizer systems.

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 characterisation 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.

>> Download the full Application Note as PDF

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