Wednesday August 15 and Thursday August 16
Day One 8:00 am – 6:00 pm Day Two 8:00 am – 12:15 pm
Bioprocess Strategies from Development to BLA
Instructor:
Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
Today’s biopharmaceutical development environment is driven by a constant stream of new modalities and product formats, an increased focus on product quality and management imperatives to advance through clinical development rapidly, and at the lowest possible cost. The Bioprocess Strategies training seminar presents a look at the key timelines and strategic considerations during the timeline and explores strategies at each step that can be employed to meet these important goals. Special consideration will be given to the role of new process and analytical technologies, automation and the use of global manufacturing and supply chain networks.
Strategic considerations in early PD
- Manufacturability evaluation
- Resource planning and allocation
- Risk assessment
- Pulling it all together
Novel modalities
- ADC
- Bispecifics
- Cell therapies
- Gene therapies
- Combination products
- High and low concentration biologics
- Biosimilars
Scale up
- Transitions from preclinical development to the clinic
- Stages of clinical development
- Commercial manufacturing
Drug product issues?
International Manufacturing and Supply
- Tech transfer
- International CMOs
- Regulatory issues
- Supply chain issues
Tech transfer
Advanced quality issues
- Role of Quality Agreements in Early Development
- Risks and mitigations
- Shared responsibilities
Advanced analytical challenges
- Expectations for potency assays
- Higher order structure
- Validation of analytical methods, how and when
Regulatory compliance challenges
- Process validation
- Control systems
- Inspections
Implementing new technologies
- Opportunities and pitfalls
Optimizing bioprocessing
- Evolving and reconfiguring older facilities
- Flexible facilities
- Automation
- Continuous processing
- Lifecycle management
Supply chain issues
- Raw material sourcing and control
- International issues
- Packaging
- Distribution
Instructor Biography:
Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
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 Ph.D. in Biochemistry from the University of Minnesota.
Training Seminar Information:
Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.
