Well Characterized Biologics & Biological Assays
November 01-02, 2022
FUJIFILM Diosynth Biotechnologies is a sponsor at Well Characterized Biologics & Biological Assays, November 1-2, 2022, College Park Marriott Hotel & Conference Center, Hyattsville, Maryland.
Join November 1, 2022 @ 2:00pm
Greg Adams, Ph.D. Senior Director, Global Analytical Strategy & Development at FUJIFILM Diosynth Biotechnologies is presenting on Piloting a Flight for the Long Haul – Method Validation Across a Biopharmaceutical’s Lifecycle
- BIO recently published a study that it takes 10.5 years for a drug to get from Phase I to regulatory approval and new ICH draft regulatory guidance’s provide updated recommendations to validate methods for commercial drug substances and products. As such, any new biopharmaceutical product entering Phase I in 2022 has a long road ahead and many questions need addressing e.g., what instrumentation will be available for commercial release in 2033? How should a phase appropriately designed validation strategy be designed? When to begin elucidation of structure studies of a complex product? This presentation will outline approaches to addressing these questions.
Join November 2, 2022 @ 4:30pm
Hunter Walker, Ph.D. Associate Principal Scientist, Analytical Development, FUJIFILM Diosynth Biotechnologies is presenting on Expanding the Mass Spectrometry Toolbox to Dig Deeper into the Personality of Protein Therapeutics
- The ‘personality’ of proteins is something that is not readily observed when reviewing the Certificate of Analysis for a biotherapeutic protein. However, it is critical to understand the personality of a protein throughout the clinical and commercial lifecycle of a molecule to have a successful, robust biotherapeutic process. Mass spectrometry is a powerful tool that can provide more sensitive and specific characterization of proteins than traditional techniques. Here, we will discuss the application of different types of mass spectrometry technology toward understanding the primary and higher order structure of proteins, post-translational modifications, and host cell and process impurities.