Using Automated Light Scattering Measurements to Support Predictive Protein Formulation Screening

This article explores how fully automated light scattering techniques that screen samples in well plates are being used to identify therapeutic protein formulations most likely to meet commercial targets during early stage development. Ideal biologics are those that are resistant to aggregation and have low-viscosity in high concentration formulation, enabling low-dose parental administration and satisfying stability requirements. Using light scattering to target formulation parameters that reliably predict stability and viscosity at high concentration helps formulators reduce the rate of costly downstream target failures and accelerate development towards clinical submission.

Key Points:

• Developing therapeutic proteins that are stable and low viscosity in high concentration formulations is important to enable daily, low-dose parental administration.
• When measured in dilute solutions, formulation parameters such as the second virial coefficient and dynamic virial coefficient correlate directly to stability and viscosity at higher concentrations.
• Measuring these properties with light scattering during the early stages of protein formulation screening helps researchers identify formulations most likely to meet this profile, reducing the risk and associated costs of failure further downstream.  
• Light scattering systems with automated well-plate sampling enable formulators to perform high throughput, low-volume screening with greater analytical productivity.
• Systems that enable sample recovery, such as the Zetasizer APS, are particularly valuable as they enable rolling stability studies to be carried out on the same sample within the same SOP.

Malvern Instruments provides the materials and biophysical characterization technology and expertise that enable scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency. Our products reflect Malvern’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment. Malvern systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications. Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, Mexico, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com severine.michel@malvern.com

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