Automation of Biologics Formulation Preparation and Stability Studies

Russell Burge

Presented by: Russell Burge, Ph.D., Applications Scientist, Freeslate, and Daniel Some, Ph.D., Principal Scientist and Director of Marketing, Wyatt Technology
Presented Live: April 9, 2015

This webinar presents Freeslate's Biologics Formulation System (BFS) which automates formulation preparation, screening and stability studies for the development of biotherapeutics. Designed in collaboration with leading pharmaceutical organizations, the BFS is an integrated workspace based on Freeslate’s laboratory robotics platform. The BFS greatly enhances productivity while exploring an expanded design space to determine the optimal formulation.

One of the key analytical tools integrated into the BFS is Wyatt's DynaPro Plate Reader. 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 BFS.

In the presented case studies, the Freeslate BFS prepared and characterized an extended series of formulations, then applied a variety of stresses. Post stress, formulations were re-analyzed to assess stability. A significant reduction in scientist time was seen as compared to traditional manual operations, yet more formulations were tested than a typical study - producing greater confidence in an optimal final selection. DynaPro temperature ramps and aggregation data were central in this accomplishment.

Topics Covered

  • How laboratory automation can be applied to biologics formulation screening and stability studies, increasing productivity and broadening the formulation design space
  • The benefits of integrating formulation preparation and analytics into a single workflow
  • The unique capabilities of high-throughput dynamic light scattering for assessing biotherapeutic formulations and stability