INTRODUCTION TO BIOPROCESSINGAugust 18-19, 2014
Day 1: 1:00 – 5:15 * Day 2: 8:30 – 5:00
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Susan Dana Jones, Ph.D., Vice President and Senior Consultant,
BioProcess Technology Consultants, Inc.
Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at the packaging of a finished drug product. The seminar also will explore emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles played by the analytical and formulation in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from receiving a detailed overview of this field.
An Introduction to Biopharmaceuticals and Bioprocessing
- Phase appropriate methods
Analytical Methods for the Characterization and Release of Biotherapeutics
- Higher-Order Structure
- Overview, role of QA and QC
- Phase appropriate Quality Systems
The Science and Technologies of Bioprocess Unit Operations
Cell Line and Upstream Development
- Expression system selection and development
- Cell banking: Master and Working Cell bank generation and testing
- Cell culture and fermentation
- Continuous feed/perfusion/fed batch
- Single use
Drug Product Development
- Liquid, Lyophilized and other forms
- Formulation development
- Device and packaging considerations
- Lyophilization and fill/finish
- Combination Products
Scaling Up Drug Substance
- Viral Validation
- Engineering and first cGMP runs
- Facility considerations
- Tech transfer
Comparability During Scale-Up and after Process Changes
Ready for Late Stage Development
- Process Qualification
- Facility Concerns
- Equipment Qualification
Ready for Commercial
- What is needed
- Supply chain considerations
Susan Dana Jones, Ph.D., Vice President and Senior Consultant with BioProcess Technology Consultants, is a seasoned biotechnology entrepreneur with experience in product development, outsourcing, and strategic planning. Dr. Jones is a subject matter expert in cell line development and characterization for biosimilar, new biopharmaceutical, and vaccine development programs. She has broad knowledge of regulatory requirements for manufacturing products for human use and has prepared CMC sections of multiple regulatory submissions. She co-founded two successful biotechnology companies including Serenex, Inc, where she worked with other senior managers to complete a $15M Series B financing. Dr. Jones was formerly VP Manufacturing at Waratah Pharma and has held positions at Dyax, Virus Research Institute (now Celldex), and the Dana Farber Cancer Institute. She currently serves on the Board of Directors of Gene Solutions, the Scientific Advisory Board of Symphogen, and is a member of the Editorial Advisory Board of BioProcess International. She received her Ph.D. in Genetics from the University of California, San Francisco.
Sheila Magil, Ph.D., Senior Consultant with BioProcess Technology Consultants, has over 20 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry, and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion, and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a Ph.D. in Biochemistry from the University of Minnesota.