(1208-A) Accelerating Formulation Development by Implementation of High Throughput Screening Workflow

Abstract: As competition and speed grow in biopharmaceutical market, an accelerated and efficient formulation development strategy may significantly facilitate the commercialization and introduction of therapeutics to the market. Implementing an end-to-end automation workflow enables the screening of a broad formulation design space in a high throughput fashion to identify promising candidates that alleviate the formulation challenges that are faced for a molecule. High throughput Screening (HTS) offers greater speed with lower time and material requirement by means of both automation and sample miniaturization.
In this poster, our focus will center on the progression path from individual HT instruments to achieving automated, fully operational workflows with nearly 100% success rate. The successful implementation of this strategy has led to timely generation of quality formulation screening data required for insightful and swift decision. We will cover the modular workflow setup and the associated advantages and disadvantages. Additionally, other necessary elements for enabling the HT operation will be introduced and the details and considerations will be provided. Strategies will be suggested to encourage the utilization of the HT capabilities in the different development studies for improved efficiency and agility. Lastly, some of the open challenges and improvement areas regarding and study design, instrument reliability, and sample sterility will be listed.