Technology Transfer & MSAT Readiness for Biologics and Complex Injectables

Technology transfer is a critical stage in scaling biologics and complex injectable products from development to commercial manufacturing. This program provides practical guidance on assessing transfer readiness across process, analytical, formulation, manufacturing, documentation and quality workstreams. Participants will learn how MSAT teams can establish governance structures, define acceptance criteria, manage risks and ensure successful internal or external site transfers. The program covers key considerations such as facility fit, equipment readiness, scale-up challenges, comparability assessment and CMO governance. The session is designed around practical industry scenarios, templates and case discussions to help teams improve transfer reliability and reduce execution risks.

Target Audience

• MSAT professionals
• Manufacturing and Operations teams
• QA professionals
• CMC teams
• Process Development scientists
• Formulation teams
• Analytical Development teams
• Project and Program Managers managing technology transfers

Learning Objectives

• Understand the scope and lifecycle of technology transfer activities
• Evaluate readiness across upstream, downstream, drug product and analytical functions
• Identify critical gaps before technology transfer execution
• Establish MSAT governance mechanisms for successful execution
• Improve transfer documentation and data package quality
• Develop mitigation strategies for transfer-related risks