TS6B: Rational Approaches to Biologics Formulation and Delivery
Day One, Wednesday 14 November 2018, 08:30-17:45 hrs
Day Two, Thursday 15 November 2018, 08:30-12:45 hrs

Room Location: Room 5A

Instructor:

Christina Vessely, PhD, 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

About the Instructor:

Christina Vessely, PhD, 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).