Biopharm process research (BPR), within the drug substance development group at GSK, is responsible for understanding and de-risking the CMC characteristics of the biopharmaceutical portfolio. In the rapidly evolving landscape of biopharmaceuticals, BPR is at the forefront of innovation, striving to deliver high-quality cell lines for commercial manufacture through an efficient and resource-conscious approach. The traditional methodology for cell line identification is heavily reliant on extensive screening processes which consume significant time and resources. This creates a challenge in managing the early-phase development of an increasingly complex biopharmaceutical portfolio, especially considering the diverse therapeutic modalities and the varying impurity profiles encountered.

To conquer these challenges, GSK has pioneered the use of data-driven digital tools designed to streamline cell line selection by aligning cell characteristics with product quality demands. This systematic approach drastically reduces the number of clones that require progression and screening, without compromising the likelihood of success in identifying optimal clones.

Central to this innovation is the integration of the Bruker Beacon Optofluidic System with proprietary OptoSelect™ technology, which has transformed the cell line development cycle. The Beacon system significantly reduces development timeframes and enhances clonal selection based on preferred phenotypes. By introducing novel assays during single cell cloning, GSK ensures the early selection of cell lines expressing the desired molecular formations, even amidst the complexities of varied impurity profiles.

Key Takeaways:

• Efficient Cell Line Development: Discover how data-driven digital tools and the Bruker Beacon system streamline the identification of optimal cell lines, reducing the need for extensive clone screening while maintaining high success rates.
• Advanced Assays for Complex Molecules: Learn about the novel assays developed for early triage of clonal cell lines, enabling the selection of those expressing correctly formed complex molecules during single-cell cloning.
• Integration of Cutting-edge Technology with Data Analytics: Explore the role of advanced data analytics, including multivariate data analysis and machine learning, in optimizing the cell line development process, backed by extensive automation in data capture and innovative experimental designs.

Join this webcast and gain insights into how GSK is driving innovation in cell line development to meet the demands of a diverse and challenging biopharmaceutical landscape.