Beating the Clock – Case Studies in Expediting Biologic Development
Summary: Biologic drug development is complex, requiring broad capabilities and expertise to ensure the highest likelihood of regulatory approval and commercial success. The journey from cell line development to clinical trial supply can result in unforeseen issues that delay timelines or require additional resources. This article presents the key factors that contribute to delays during biologic development, as well as best practices for risk mitigation during development and manufacturing. Three case studies are discussed as solutions for the management of these challenges.