Biologic drugs can be inherently prone to degradation and instability and often pose challenges to developers designing safe, stable and effective formulations. To overcome these issues, developers perform screening and stability studies to identify suitable formulations for development. But due to resource limitations, the number of formulations screened is often constrained.
By automating formulation preparation, screening and stability studies, companies can increase their productivity by expanding throughput without additional resources. Designed in collaboration with leading pharmaceutical organizations, the Biologics Formulation System is an integrated workspace based on Freeslate’s laboratory robotics platform.
One of the key analytical tools integrated into the Biologics Formulation System is Wyatt Technology's DynaPro Plate Reader II. The DynaPro employs dynamic light scattering (DLS) to characterize molecular size distributions in order to quantitatively assess aggregation, conformational changes, propensity for aggregation and viscosity. The DynaPro is one of several analytical instruments supported by the Biologics Formulation System.
In this study, we evaluated the application of the Biologics Formulation System for formulation screening and stability studies. The system prepared all formulations and measured their viscosity, color, visible particles, turbidity, protein concentration, protein aggregation and protein stability. Formulations were subjected to stress both on and off system. Post stress, formulations were analyzed to qualify their performance. By applying automation, a 4x-6x reduction in scientist time was seen as compared to performing the study manually.
In the presentation, results from the formulation stability study and the efficiency we recognized through automation will be presented.
Presented by
Russell Burge, Ph.D.,
Applications Scientist
Russell is an Applications Scientist at Freeslate where he designs and performs demonstrations of automation systems, which are used in the research and development of pharmaceuticals. He earned a Bachelor of Science degree in biochemistry from Arizona State University. Russell obtained a Ph.D. in molecular biology and biochemistry from the Scripps Research Institute. After graduation, Russell received post-doctoral training at the University of Colorado. During post-doctoral training, Russell worked on the biophysical characterization of RNA and DNA aptamers relevant to the biopharmaceutical industry.
Dr. Daniel Some,
Principal Scientist and Director of Marketing
Dr. Daniel Some is Principal Scientist and Director of Marketing at Wyatt Technology Corporation. As Principal Scientist he investigates techniques for characterization of macromolecular interactions, contributing to the development of new instruments and applications. As Director of Marketing, Dan believes that Wyatt’s success can only be achieved through that of Wyatt's users, and endeavors to connect customers with the right solutions to their analytical challenges.
