Description

Prefilled delivery systems continue to gain popularity in numerous market segments and this trend is expected to continue in the coming years. The reasons for this are numerous and include migration of care to non-traditional settings, increased compliance and safety, and market differentiation. This course will provide an in depth review of the challenges and opportunities associated with the qualification of prefilled delivery systems. The fundamentals, along with a comprehensive review, will be provided on the elements necessary to establish a program to evaluate, qualify, and ultimately validate prefilled delivery systems. Participants will also gain a thorough understanding of the currently available devices and gain tangible guidance on appropriate analytical methodologies and strategies necessary to implement and utilize in developing their own prefilled device programs. Case studies that add relevance to the lecture materials and provide a launch point for class discussion will also be presented.

Agenda

• Introduction to Prefilled Delivery Systems
  • historical perspectives on the use of prefilled delivery systems
  • market trends and expectations
  • device overview and options
• Comparison of Small Molecules, Biologics, and Vaccine Needs Relative to Prefilled Devices
• Elements of a Device Qualification and Commercialization Program
  • bioanalytical
  • formulation
  • regulatory
  • stability
  • marketing
  • putting it all together
• When to Transfer Molecules from Discovery to Process Development
• The Vial to Prefill Conversion Process (pre and post launch)
• Designing a Comprehensive Evaluation and Stability Program
  • extractables and leachables
  • system based vs. component based
  • assessing drug product interactions
  • auto injectors
  • integrated safety
• Regulatory Considerations in Device Development
  • defined and undefined guidance
  • setting specifications and limits
  • the science based regulatory approach for devices
• Lifecycle Management

Who Should Attend?

This course is intended for project and Program Managers, Scientists, Managers, Directors, QC/QA and regulatory affairs personnel who are directly concerned with product development and testing.

Instructor

Justin Wright, Ph.D., Manager, Bio-Analytical Sciences, BD-Medical Pharmaceutical Systems
Justin Wright holds a Ph.D. in bioorganic chemistry from Clemson University and he spent two years as a postdoctoral fellow at Harvard Medical School where he studied DNA bulge specific scission and protection agents. He then joined Merck & Company where he spent seven years in process development, leading efforts in commercialization of new products, franchise management, external manufacturing, and strategic sourcing. In early 2007, Dr. Wright joined BD-Medical Pharmaceutical Systems where he currently serves as BD's primary technical interface for the Biotech, Vaccine, and Pharmaceutical industries in developing and commercializing complex and sensitive drug products in pre-filled drug delivery systems. His current research interests include developing novel approaches and test methods for assessing drug product compatibility in primary packaging and defining scientific strategies for regulatory compliance. Dr. Wright is a member of the American Association of Pharmaceutical Scientists, Parenteral Drug Association, and the American Chemical Society. He is the author of more than 20 patents and publications.