Accelerating Antibody Development: A Proven Path From Gene To GMP

Accelerating monoclonal antibody (mAb) development without sacrificing quality or regulatory readiness remains a major challenge for biopharmaceutical sponsors. In this webinar, Catalent experts discuss how the company’s Rapid Antibody platform streamlines the path from gene of interest (GoI) to GMP-ready drug substance in as little as eight months.

By running cell-line development, process development, analytical testing, and formulation activities in parallel, the platform reduces traditional bottlenecks and helps sponsors stay on track for critical development milestones. Attendees will learn how Catalent’s GPEX Lightning cell line supports rapid generation of stable cell pools, early productivity assessment, and faster progression to clone selection and scale-up.

The session also explores the platform’s milestone-based approach, including technologies such as the Ambr 250 bioreactor system and the Beacon high-throughput screening platform, as well as the key molecular and program characteristics that enable accelerated timelines. Along the way, speakers will share how the integrated strategy supports informed decision-making, regulatory confidence, and reliable execution from development through manufacturing.