Ina Sarel

Ina Sarel

Company: Nurexone Biologic

Job title: Head of Quality, Regulatory, Chemistry, Manufacturing & Controls


Regulatory Challenges in the Development of an Extracellular Vesicle-Based Clinical Product 1:05 pm

In this workshop we will discuss how to navigate the intricate regulatory requirements to translate extracellular vesicles loaded with PTEN-siRNA (ExoPTEN) from preclinical to clinical phase. Strategies for the manufacturing process and controls include: Scaling up the bioprocess to produce higher yields and quantities. Development of a proprietary moiety for efficient loading of siRNA Establishing…Read more

day: Pre-Conference Workshop Day

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