Steve Soltys

Steve Soltys

Company: Kriya Therapeutics

Job title: VP, Process Development


Scaling the Manufacturing Process: The Importance of Small Scale Models in Supporting Comparability Assessments 8:45 am

Animal models provide a critical framework for the preclinical evaluation of gene therapy products. The vectors generated for these nonclinical studies are typically made at a lab scale using a process that differs from the eventual clinical and commercial manufacturing processes. Often, these lab processes utilize techniques that are not scalable, resulting in impurity profiles…Read more

day: Day Two

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