This workshop provides an overview of fundamentals and challenges for formulation development spanning from preclinical optimization to post marketing manufacturing.   Key concepts such as protein design and characterization, early formulation screening, stability evaluation including aggregation and  subvisible particles, analytical methodologies, high-concentration formulation and device interface, and formulation/process robustness using Quality-by-Design principles.  It features case studies and interactive discussions on a wide-range topics and issues encountered during protein optimization, formulation design to technology transfer and commercialization.

This workshop will benefit scientists, analysts, research associates, managers, directors, regulatory affairs, quality control, quality assurance, and device and process engineers currently working in the biotechnology industry who want to improve their understanding of the best practices in formulation development for proteins. This workshop is also useful for non-pharma scientists who seek better technical understanding of processes, challenges and opportunities in the industry.

Speakers:

Robert Kelley (Genentech), Aditya Wakankar (Stem CentRx), Hung-wei Chih (Genentech)

The following key topics will be discussed.

• Design of proteins and antibodies with delivery in mind
• Leverage platform and automation to accelerate formulation development for early clinical development
• Important considerations to develop a robust formulation and process for Ph III and registration
• Challenges encountered during commercial manufacturing and lessons for formulation design