Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.
TS12B: Introduction to Bioprocessing
WEDNESDAY, MAY 6 - THURSDAY, MAY 7
DAY 1: WEDNESDAY
8:40 am - 6:00 pm Seminar Sessions
12:30 - 1:30 Lunch Provided
6:00 - 7:15 Taste of New England Networking Reception in the Exhibit Hall with Poster Viewing
DAY 2: THURSDAY
8:30 am - 12:30 pm Seminar Sessions
Exhibit Hall Refreshment Breaks also provided.
Instructors:
Sheila Magil, PhD, Managing Director, Industry Specialized Services, BDO
Frank Riske, PhD, Managing Director, Industry Specialized Services, BDO
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 scaling up for commercial production. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods at all stages of development as well as formulation and stability assessments 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 a detailed overview of this field.
Topics to Be Discussed:
An Introduction to Biopharmaceuticals and Bioprocessing
Analytical Methods for the Characterization and Release of Biotherapeutics
- Structure-function
- Bioassay
- Higher-order structure
- Phase-appropriate methods
Quality Systems
- Overview
- Quality by Design (QbD)
- 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 development
- Continuous feed/perfusion/fed batch
- Single use
Recovery and Downstream Development
- Affinity capture
- Platform processes
- Purification development strategies
- Polishing and final processing
- Viral clearance validation
Drug Product Development
- Liquid, lyophilized and other forms
- Formulation development
- Device and packaging considerations
- Combination products
Scaling Up Drug Substance
- Considerations in scaling up
- 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
- BLAs/NDAs
Instructor Biographies:
Sheila Magil, PhD, Managing Director, Industry Specialized Services, BDO
Sheila Magil 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 PhD in Biochemistry from the University of Minnesota.
Frank Riske, PhD, Managing Director, Industry Specialized Services, BDO
Frank J Riske, Ph.D., has over 30 years of experience in the biopharmaceutical industry and has been involved in the development, or improvement, of eight commercial protein products. Prior to joining BPTC four years ago (and more recently the BioProcess Technology Group at BDO; after BPTC acquisition), Dr. Riske was a Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. At Genzyme, Dr. Riske was responsible for the development of late stage downstream processes for recombinant enzymes, monoclonal antibodies, Adenovirus (gene therapy) and the identification and exploration of new technologies, including continuous processing, to streamline and improve purification. Prior to joining Genzyme, Dr. Riske managed the development, implementation and manufacture of a peptide bound within a novel sustained release vehicle, and the development of a next generation process to purify IVIG from plasma (both at Epic Therapeutics). Before Epic, Dr. Riske held positions at Repligen and Hoffmann-LaRoche during which he developed and improved, downstream processes for proteins produced in mammalian cell culture, E coli, and Pichia systems. Dr. Riske was also responsible for the manufacture of MAb fragments at Repligen. Dr. Riske has published over twenty peer reviewed papers and patents and is active in the scientific community as both a mentor to young scientists and as a conference speaker and organizer. Dr. Riske received his B.S. in Biology from Fairfield University, Ph.D. in Biochemistry and Microbiology from Rutgers University and completed a post-doctoral position at Hoffmann-LaRoche.
WHAT IS A TRAINING SEMINAR?
Each CHI Training Seminar offers 1.5 days of instruction, refreshment breaks, exhibit hall functions, and lunch for all registered attendees on the full day of the class. Each person registered for the Training Seminar will be provided with a hard copy handbook for the Training Seminar in which they are registered. A limited number of additional handbooks may be available for other delegates. CHI encourages track hopping between conference programs, and we ask that Training Seminars not be disturbed once they have begun. We ask that attendees commit to attending the entire 1.5-day training, and not engage in track hopping once the class has started.
