Accelerating the Development of Drug Formulation Design with Modern High Throughput Experimentation Analytical Techniques

Sunday, March 06, 2022: 2:10 PM - 2:45 PM

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Description

Advances in high throughput automation - both with regards to platforms and analytical instrumentation - have generated growth in drug discovery and product development experimentation processes. Initially, automation platforms limited their focus on aqueous and organic solubility studies. As capabilities have improved, more functionality has been introduced which provide for more opportunities to characterize drug molecules from earlier in the candidate selection phase through to product development. The scientists at GSK’s high throughput experimentation (HTE) lab, in Collegeville PA, have deployed a variety of automation equipment to drive their investigations. These systems include Unchained Labs CM3 robotic platforms, Mettler Toledo Quantos & Chemspeed powder dispensing platforms, and Hamilton & Andrew liquid dispensing platforms. As focus has intensified in preparing long-acting injectable (LAI) drug products, the HTE lab has developed unique protocols for determining partition coefficients, viscosity measurements, version and form analysis, formulation stability, and excipient compatibility. Because this data can be produced with small amounts of precious drug substance, HTE enables critical-path decisions to be made earlier in the process, with benefits that include bringing new molecules to the patient sooner and at lower cost. This presentation will focus on several HT experimental designs and how they are applied to LAI formulations. Specifically, we will discuss the measurement of distribution coefficients, viscosity, and design of experiments for LAI pre-formulation studies. The results of this work are informative for developing final formulation designs with appropriate excipient concentrations which ultimately produce our clinical trial materials.

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Track(s)

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  Pharmaceutical

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Additional Info

Category: Please choose one (1):
Pharmaceutical/Biologics

Keywords: Please select up to 4 keywords ONLY:
Chromatography - Other,Method Development,Particle Characterization,Sample Preparation