Tutorial 13: Technology Transfer for Biopharmaceuticals Workshop

Technology Transfer such as change of manufacturing site or scale is crucial during the product/process development lifecycle.  Poor planning, management and execution of technology transfer can result in major project impact and cause several months delay at each occurrence, leading to a cumulative effect on cost and time, and delayed clinical material.  In this tutorial we will provide an overview of some of the practices and principles of Technology Transfer including process and analytical methods transfer and acceptance criteria, process and product comparability, risk management, outsourcing, regulatory guidance; as well as including worked-through case studies. The tutorial will be highly interactive with team based practical exercises which will examine the basic concepts of technology transfer and progress this through to real life scenarios.  The tutorial will provide you with the ground tools of technology transfer to enable you to plan effectively and limit the risk of technology transfer on the critical path.

Scientists and managers working in the areas of process and analytical development, current good manufacturing practices (Cgmp), strategic decision making

 

At the conclusion of this tutorial, attendees will be able to:

• Recognise the fundamental concepts and different stages of technology transfer 
• Translate the principles of technology transfer into working practice