Description

An increase in the outsourcing of biopharmaceutical manufacturing (both clinical and commercial) has led to an increased emphasis on technology transfer. Despite the increased emphasis, companies are reluctant to spend the upfront time, money, and planning that is needed for tech transfer other than "to go and do it". The result is delayed launches, wasted time and an impact to the bottom line. This course is designed to explore the technical aspects of process and analytical transfer that are needed as an organization decides to embark upon a manufacturing process transfer from one location to another, whether it is an internal transfer or an external transfer. Upstream and downstream process transfers will be considered along with the regulatory compliance requirements for cGMP manufacturing. Issues associated with international technology transfers will be also be discussed. In addition, the importance of strong project management and the creation of cross-functional teams will be emphasized. The financial rationale behind doing a "right transfer" will also be presented.

Agenda

• Fundamentals of Technology Transfer
  • importance of tech transfer
  • different stages of tech transfer
  • stakeholders in tech transfer
• Challenges and Opportunities in Process Transfer
  • transfer of an upstream process
  • transfer of a downstream process
  • development of tech transfer protocols
  • transfer of validated processes
• Challenges and Opportunities in Analytical Transfer
  • transfer of methods in development
  • transfer of methods in a CGMP setting
  • development of tech transfer protocols
• Developing Technology Transfer into a Core Competency
  • risk assessments
  • tech transfer by design
• Financial Impact of Technology Transfers
• Importance of Project Management During Technology Transfer
  • utilization of project management tools and principals
  • defining tasks and milestones
  • tracking progress
  • cross-functional teams and communication
• Technology Transfer Considerations during Outsourcing
  • importance of contractual and quality agreements
  • special considerations for international "outsourced" transfers

Who Should Attend?

• Managers, Scientists and Associates working in process and analytical development who are involved with the technology transferring of biotechnology processes and analytical methods
• Manufacturing and quality professionals
• Scientists from Discovery, Product Development and supply chain Management

Instructor

Siddharth (Sid) J. Advant, Ph.D., Principal, Tunnell Consulting
Sid Advant currently serves as Principal and Head of Tunnell Consulting's West Coast Office, where he is responsible for growing Tunnell's biotechnology consulting business. Prior to joining Tunnell Consulting, Sid was a Director at Diosynth Biotechnology with increasing responsibilities in Pharmaceutical Sciences (Analytical & Formulation Development, Release & Stability Testing), Technology Transfer, Project Management and Business Alliances, and was involved in the development of more than 25 therapeutic proteins. Prior to Diosynth, Sid worked at BioReliance and Protein Design Labs; where he was responsible for setting up formulation development groups. Sid has presented at many national and international conferences on the challenges and opportunities in technology transfer of biopharmaceuticals. Sid received his Ph.D. in Pharmaceutics from the University of Connecticut and his B.S. from University of Poona, India.