Toby Hong

Associate Director of Analytical/Formulation Development & Cell Line/Cell Culture Process Development
Bora Biologics

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Dr. Toby Hong is a biopharmaceutical scientist and leader with over a decade of experience in biologics development, specializing in bio-analytical method development. As Associate Director at Bora Biologics in Taiwan, Dr. Toby Hong leads cross-functional teams to deliver innovative, high-quality biologics solutions, overseeing assay development, method qualification/validation, compliance and CMC support.
Prior to Bora, Dr. Toby Hong was Associate Director of Process Science at Eden Biologics (formerly JHL Biotech), managing scientists across CDMO and pipeline projects. From 2013 to 2022, they held roles of increasing responsibility, contributing to IND submissions, biosimilarity assessments, and CDMO success, while also establishing GLP/GMP-compliant labs and implementing advanced processes for biologics manufacturing. His work includes a U.S. patent on nucleic acid-enzyme clippnig assay.
Dr. Toby Hong earned a Ph.D. in Biological Sciences from Clemson University and completed a postdoctoral fellowship at the University of Chicago Medical Center, focusing on leukemia and stem cell biology. With broad technical expertise in molecular biology, protein chemistry, immunology, and in vivo models, Dr. Toby Hong continues to drive scientific excellence and therapeutic innovation.

 

Speech title & Synopsis

Bioassays Development for Product Release and Characterization  - From a CDMO Perspective

This presentation provides an overview of the development of bioassays for the characterization and release of biopharmaceutical products, with a particular focus on the unique role and challenges faced by Contract Development and Manufacturing Organizations (CDMOs). It will explore the strategic considerations involved in selecting and designing suitable bioassays that align with regulatory expectations and client-specific product requirements. Attendees will gain insights into assay lifecycle management. Real-world examples will highlight how CDMOs navigate timelines, resource constraints, and multi-product pipelines while ensuring robust, reliable, and phase-appropriate assay development. The session will also touch on emerging trends, such as automation, that are shaping the future of bioassay development in a CDMO setting.