From Transfection to FIH in 6 Months: How Advances in Cell Line Development Enabled Manufacturing of Monoclonal Antibodies at An Unprecedented Pace
Simon Fischer, Senior Principal Scientist and Head of Cell Biology at Boehringer Ingelheim
In this presentation, Simon presents a case study that resulted in the successful accelerated development of GMP-grade antibody-based therapeutics for early clinical studies at a commercial scale of 2,000 L. Simon demonstrated how applying innovative cell line generation approaches such as Transposase-Mediated Semi-Targeted Transgene Integration (STI) together with digital technology, resulted in the production of high-quality drug substance in less than 3 months (compared to 16-24) from stable pools allowing the first Phase I clinical trials only 6 months after transfection. Using the generated stable pool allowed the generation of a clonally derived production cell line within just 8 months. Genedata Selector®, an advanced enterprise platform that simplifies and automates NGS data processing and analysis, allowed in-depth genetic characterization of the cell pool and monoclonal cell line, a cornerstone of a thorough cell line development process.
This talk was given as part of our regular virtual events focused on biosafety and cell line development and is based on this publication.
Who should watch:
Biopharma and biotech professionals undergoing cell line development looking to significantly accelerate the development of GMP-grade antibody-based therapeutics by embracing digitalization and innovative enterprise data analysis systems.