Ina Sarel

Company: NurExone Biologic

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

Seminars:

Roundtable Discussion: Harmonizing the Exosome & Extra-Cellular Vesicle Regulatory Landscape Towards Better Definitions, Practices & Guidelines for Therapeutic Success 9:30 am

What are the current gaps in knowledge of submissions, and what can we learn from current therapeutic progress in the clinic? How does the current regulatory guidance provide clarity on CMC changes for exosome-based therapeutics? How can the exosome biopharma industry and regulators continue to support each other to ensure global harmony and better therapeutics…Read more

day: Conference Day Two

Advancing the Effective Production & Scale-Up of Exosomes Towards GMP-Grade Compliance 11:00 am

How to effectively scale exosomes for GMP-grade manufacturing from research to clinical Exploring strategies for minimizing batch-to-batch variations by optimizing sourcing processes, culture conditions, and ensuring uniformity in starting materials for efficient scale-up Ensuring quality EV isolation from a purified population of the right cell types and consistent supply using scalable processes NEW DATA!Read more

day: Conference Day Two

Roundtable Discussion: Utilizing the Most Optimal Analytical Assays to Support Your Exosome Drug Product Release Strategies 2:30 pm

Evaluating conventional and novel instruments to analyze exosomes across ELISA, acoustic Imaging, flow cytometry, and more to confidently select your technology Ensuring analytical methods are validating, qualifying, and reproducible to ensure safety and sterility of the exosome product One vs multiple potency assays – How to address complex mechanisms of action within the production phaseRead more

day: Pre-Conference Focus Day