Kok Seong Lim
Independent Cell & Gene Therapy CMC Expert Independent Expert
Kok-Seong Lim, BPharm, PhD, is a pharmaceutical leader with over 20 years of experience in biological research and development, specializing in analytical sciences, quality control, and CMC strategy for advanced therapy platforms. He has held multiple management roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific (formerly Brammer Bio), where he contributed to the advancement of more than 10 gene therapies and CRISPR-based medicines for rare diseases and oncology indications.
Throughout his career, Kok-Seong has led the buildout of GMP-compliant facilities and analytical infrastructures to support early- and late-stage development. He has successfully managed complex, multimillion-dollar budgets and contributed to regulatory submissions in both the U.S. and EU. An active industry contributor, Kok-Seong regularly presents at conferences and has served on committees such as the U.S. Pharmacopeia Biologics Expert Committee for Cell and Gene Therapy and the Standards Coordinating Body, helping to shape best practices and standards for the cell and gene therapy field.
He earned his PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde.
Seminars
- Clarifying what “cell-free” production really entails and how it differs from enzymatic or synthetic methods
- Comparing structural and impurity profiles across different DNA production approaches
- Exploring scalability, process flexibility, and cost implications of each method
- Sharing practical experiences and lessons learned from implementing different synthetic DNA platforms
- Analyzing mechanistic sources of dsRNA including self-priming and sequence context effects
- Exploring analytical approaches for dsRNA detection and quantification
- Identifying strategies to minimize dsRNA formation and its impact
