Fast-tracking gene therapy breakthroughs: discussing the critical role of rapid testing

Cell & Gene Therapy Insights 2023; 9(11), 1553–1560

DOI: 10.18609/cgti.2023.204

Published: 5 January
Expert Roundtable
Rachel Legmann, Garima Thakur, Seth Levy, John Long

In this Expert Roundtable, four industry experts, Rachel Legmann, Garima Thakur, John Long, and Seth Levy debate strategies to overcome analytical testing hurdles in gene therapy development and manufacturing, particularly surrounding gene therapy’s need for speed in at-line and in-line testing.

Rachel Legmann has more than 20 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vectors and proteins for gene therapy and biologics. She completed her PhD in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Repligen in 2021 as a subject matter expert offering technical assistance to help customers achieve their technical and operational objectives in their manufacturing of virus-based therapeutics with a focus on gene therapy processes including upstream, downstream, analytics, and scalability. In addition to supporting global customers and building high level networks, Legmann is supporting various internal cross-functional activities and external collaborations. Prior to joining Repligen, Legmann held several scientific and leadership roles at the Department of Microbiology and Molecular Genetics at Harvard Medical School, CRO SBH Sciences, Seahorse Biosciences (part of Agilent), CDMO Goodwin Biotechnology, and Pall Corp part of Danaher.

Garima Thakur is currently a Process Development Engineer in the Viral Production Core team of the Preclinical Manufacturing and Process Development group at Regeneron Pharmaceuticals. Her role includes technology development for novel rAAV-based therapies, production at 2 L, 50 L, and 500 L scale for preclinical trials and toxicology, as well as tech transfer to cGMP. She recently completed her PhD in Chemical Engineering at the Indian Institute of Technology, Delhi. Her work focused on process analytical technology for monitoring and control of continuous manufacturing processes for monoclonal antibodies.

John Long holds the position of Director, Analytical Methods at Aldevron, and has over 20 years of experience working in analytical methods for large molecule therapeutics including vaccines, biologics, and gene therapy products.

Seth Levy, Senior Director of Bioprocess Development at Modalis Therapeutics, has built and oversees internal process development and analytics efforts, as well as manages external manufacturing. Prior to Modalis, Seth led teams in manufacturing science and technology and small-scale development for AAV and LV manufacturing at Viral Vectors Services. Seth worked in gene therapy R&D before his time at a CDMO and drove numerous AAV projects including basic biology research, capsid engineering, and translational gene therapy approaches at Sanofi Genzyme and academia.