Wednesday 20 November and Thursday 21 November
Day 1
8:30 – 17:45 Training Seminars in Session
12:45 Lunch Provided
17:45 – 18:45 Networking Reception
18:45 – 19:45 Problem Solving Breakout Discussions
Day 2
8:30 – 12:45 Training Seminars in Session
Refreshment breaks and exhibit hall viewing hours also provided
Instructor:
Christina Vessely, PhD, RAC, Senior Consultant, CMC, Analytical and Formulation Development, Biologics Consulting
Objectives:
This course is intended to give participants an understanding of the basic principles of biologics formulation development, with an emphasis on maintaining long term product stability. Participants should expect to come away with a better understanding
of biochemical and biophysical properties of proteins and peptides, and how excipients and other strategies can be used to mitigate degradation. Formulation development discussions will cover both liquid and lyophilized dosage forms.
The focus of the session will be on maximizing efficiency during formulation development, with an eye on regulatory compliance throughout the product development lifecycle. As such, following the introduction to formulation development, we will cover
more complex formulation development topics including strategies for the formulation of low solubility API’s, advice for the selection of container/closure systems and drug delivery devices, as well as the studies that must be performed to demonstrate
the compatibility of those materials with the product.
Topics include:
- Basics of protein biochemistry and biophysics, protein folding, and protein degradation mechanisms
- Different options for formulation development studies including matrix-based designs and DOE studies
- The development of lyophilized formulations and the basics of lyophilization cycle development
- Biochemical and biophysical analytical characterization tools
- QBD and the formulation scientist
- Utilization of data obtained during formulation development for determining critical quality attributes
- Responsibilities of the formulation scientist throughout the product development lifecycle
- Formulation development
- Container/closure and device selection
- Material compatibility studies
- Justification of formulation parameters and ranges
- Bringing it all together for the regulators
- Special formulation challenges
- Antibody-Drug conjugates
- Bispecifics/multi-specifics
- Fusion proteins
- Cell therapy products
- Gene therapy products
- Poorly soluble molecules
Instructor Biography:
Christina Vessely, PhD, RAC, Senior Consultant, CMC, Analytical and Formulation Development, Biologics Consulting
Christina Vessely, PhD, RAC,
has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization
for mid-sized and large pharmaceutical companies. She has been involved in priority review and fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies
and evaluation of GMP systems, as well as the authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).
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.
