Training Seminars

TS6B: BIOPROCESS STRATEGIES FROM DEVELOPMENT TO BLA

WEDNESDAY, AUGUST 14 AND THURSDAY, AUGUST 15
DAY ONE: 8:00 AM – 6:00 PM | DAY TWO: 8:00 AM – 12:15 PM

Instructor:

Sheila G. Magil, PhD, Managing Director, Industry Specialized Services, BDO

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.

TOPICS TO BE DISCUSSED:

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?

  • Delivery modalities

International Manufacturing and Supply

  • Tech transfer
  • International CMOs
  • Regulatory issues
  • Supply chain issues

Tech transfer

  • Sites
  • Countries
  • Stages

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:

Magil_SheilaSheila G. 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.

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.