4 ANALYTICAL AND LABORATORY EQUIPMENT
Fig. 1. Malvern Zetasizer systems.
that examined the effects of pH, temperature and concentration on oligomerisation and aggregation behaviours. Te 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 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.
Light scattering techniques support formulation development
Researchers develop methods to test protein stability under a variety of conditions.
Les chercheurs de développer des méthodes pour la stabilité des protéines d’essai sous une variété de conditions.
Forscher Testproteins Stabilität unter einer Vielzahl von Bedingungen.
R
esearchers 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.
Tese rAlbumins have been developed and optimised to deliver a safe, stable and regulatory- compliant product for therapeutic formulations.
Te 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.
Te work is described in an article
www.scientistlive.com
‘Tools for evaluating the stability of human recombinant albumins used in human therapeutics’. See:
www.malvern.com/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. Te 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
Malvern offers a growing range of systems for protein characterisation. Te 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.
Te 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.
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.
DLS Microrheology With the recent launch of the new top of the range Zetasizer Nano ZSP system (Fig. 2), Malvern Instruments has added dynamic light scattering (DLS) Microrheology to its portfolio of materials characterisation techniques.
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