Process development innovations to improve gene therapy manufacturing

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Live30 webinars are thirty minute presentations designed to update you on the latest innovations, applications and data in a fast yet interactive format.

As viral vector-based gene therapies move toward indications with larger patient populations, the pressure to improve manufacturing efficiency is rising. To support efficient manufacturing, therapeutic developers must begin by putting a robust process development (PD) plan in place. The industry has been working towards a robust PD plan using innovation, such as, templated processes to improve yield while reducing costs of goods sold (GOGS) and time-to-clinic. While templates will help, there will always be a need for PD to optimize the upstream/transfection, as well as downstream due to differences in the gene of interest (GOI). In this panel style webinar, our experts will discuss the PD innovations that our teams are working on to improve manufacturability, robustness of analytical testing, and scale-down models to meet the needs of large-scale manufacturing.

Process Development is a critical service to support robust manufacturing of viral vector-based therapies.
Without a proper PD plan in place, outcomes include manufacturing failures, product impurities, low titer/yield, increased costs to developers and more time spent on product release.
Continued innovations in PD are necessary to industrialize the industry and support successful large-scale manufacturing.
Our design of experiment (DOE) studies have optimized upstream and downstream processes.
How we can help map out your process and assess manufacturability

Jessica Hilmoe

Technical Leads Manager MilliporeSigma

Jessica Hilmoe is a Technical Leads Manager for the Manufacturing and Operations of Viral Gene Therapies at MilliporeSigma. She brings eighteen years of experience in the biotechnology industry with sixteen years focusing on Viral Gene and Cell therapies. Her background is in Manufacturing Operations, Process Development, and Technology Transfer. She managed the Technology Transfer group at the Carlsbad facility for three years before taking on the Technical Leads group covering global territory. She is currently involved in evaluating proposed commercial processes, helping early phase clients with designing scalable manufacturing processes, and later phase clients with creating a road map of process validation activities to enter the commercial lifecycle.Prior to joining MilliporeSigma’s team, she worked for Genzyme Gene Therapy Operations in San Diego, CA, focusing on upstream process development and technology transfer, and Shire in San Diego, CA leading Manufacturing Tech Support analytical group.She received B.S. in Cellular and Molecular Biology from San Diego State University and an MBA from the University of Maryland.

Michael Shen, Ph.D.

Associate Director, Process Development, MilliporeSigma

Michael is the Associate Director of Process Development at MilliporeSigma’s new state of the art viral vector CDMO facility in Carlsbad, CA. In this role, he leads a team responsible for the development of viral vector production processes and analytical methods. Prior to MilliporeSigma, he held various positions in process development and manufacturing of monoclonal antibody and protein therapeutic products, with experience in taking projects from cell line development to FDA filing. He holds a Ph.D. degree in Chemical Engineering from the University of California, Irvine.