Biotech Lunch & Learn: Contemporary Analytics and Formulation Approaches

Description

Speaker: Greg Adams, Ph.D., Senior Director, Global Analytical Strategy & Development, FUJIFILM Diosynth Biotechnologies

Proteins are molecules of delicate three-dimensional structures that are made of unique primary, secondary, tertiary, and quaternary structures that give each protein a unique “personality”. As analytical and formulation scientists, we seek to understand their unique personality and must make use of the appropriate tools to do so. We will also discuss the balance between a “need for speed” and the execution of “good science”.
In this presentation we will focus on:

• Ensuring that the analytical methods that evaluate quality attribute of proteins are reproducible and robust
• Knowing your design space to rapidly deliver early phase programs
• Designing methods with a line of sight from initial development through cGMP manufacture
• Ensuring consistent analytical data throughout the clinical lifecycle
• Speed is good, science is better. A balance between the two is best.