Dr. Maria Badal Tejedor is associate principal scientist at Cepheid.

She is responsible for the lyophilization research strategy to improve drying cycle efficiency and product stability. Maria has M.Sc in Chemical Engineering from the University of Zaragoza and a Ph.D in surface chemistry applied to pharmaceutics from KTH, Royal Institute of Technology in Stockholm. Her background is in pharmaceutical formulation and development of different oral forms. Her interests also include drug delivery and process technologies for different pharmaceutical dosage forms and drug molecules.

Abstract

Lyophilized beads are spheres made of lyophilized material containing a certain concentration of selected components. They are a very versatile system that provides long term stability, quick reconstitution, and easy handling. Lyobeads are not limited to, but widely used to stabilize diagnostic reagents. Besides the stress implied in lyophilization, the processing of the bulk solution and later bead handling must be considered when designing the bead formulation. The lyobead system also allows for adjustment of the lyophilization process parameters to run faster and more aggressive drying cycles. Efforts have been made to design a lyophilization cycle that provides the right amount of energy to keep the frozen system in balance without collapsing until sublimation has been completed and the product fully dried using a single drying step. Critical process parameters such as pressure and shelf temperature in correlation to the product temperature profile and bead loads will be discussed and linked to different formulations.

Highlights
• Considerations for lyophilized bead formulation
• Freeze-drying critical process parameters and in-process controls
• Lyobead drying process experimental setup and evaluation