What do Regulatory Agencies Really Expect for Comparability during Process Optimization and Scale-up?

May 26, 2010 | 12:30 - 2:00 PM EST

Course Instructor: Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants

Discussion Topics Include:

• Critical Quality Attributes-what are they and how do you control them during process scale-up?
• How is scale-up likely to change your product?
• How big an impact does a change in production cell line have?
• This course will use case studies to provide a roadmap for the critical issues facing companies today as they rigorously try to meet regulatory expectations
• Comparable is NOT identical-we’ll describe what changes are good, what ones are neutral, and what is unacceptable in today’s environment.
• Yield and purity requirements-the sliding scale throughout the development cycle

 

About the Instructor
 Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants
Susan Dana Jones, Ph.D., has more than 20 years of discovery, product development, and strategic planning experience in biotechnology. She co-founded two biotechnology companies and has managed discovery and product development programs in multiple organizations and for multiple disease areas. She currently manages several outsourced biopharmaceutical process development and manufacturing programs for client products, assists and advises clients and vendors regarding applicable cGMP regulatory guidelines, performs regulatory compliance audits, prepares CMC sections of client regulatory submissions to FDA, EMEA, and other competent authorities, and performs due diligence of manufacturing and analytical operations for investors or clients considering acquiring products in development. In addition, Dr. Jones serves as a guest lecturer at Northeastern University, as a member of the Board of Directors of Virginia-based start up company Gene Solutions, and as a member of the Editorial Advisory Board of BioProces- International. Prior to joining BioProcess Technology Consultants, Dr. Jones was Senior Vice President of Corporate Development at Serenex, Inc, where she worked with other senior managers to complete a $15M Series B financing. She was previously Vice President of Product Development at Waratah Pharmaceuticals, where her responsibilities included management of outsourced product development and manufacturing activities for a combination protein and peptide therapeutic. Before Waratah, Dr. Jones held development and management positions of increasing responsibility at Peptimed Inc., Virus Research Institute (now CelldexImmunotherapeutics), IntraImmune Therapies Inc., and Dyax Corp. Dr. Jones received her Bachelor's degree from Harvard University, her Ph.D. from the University of California, San Francisco, and performed post-doctoral research at the Dana-Farber Cancer Institute of Harvard Medical School.