Webinar: Assessing E&Ls from Single-Use Systems

Assessing E&Ls from Single-Use Systems Used in ATMP Production

Single-use systems are popular in CGT development, but they can release chemicals known as extractables and leachables (E&L). Identifying E&Ls early is critical to protecting patients and meeting regulatory expectations.

In this webinar, we share new data on the effects of E&Ls on human cells.

What You Will Learn:

Learn about qualifying single-use solutions for ATMPs with a focus on E&Ls.
Explore high-throughput cell-painting assays and how E&Ls affect cells in vitro. 
See how Sartorius supports process qualification with data packages and software.

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Dr. Armin Hauk

Principal Scientist

Armin Hauk has held the role of Principal Scientist at Sartorius since 2016. After his PhD, he worked for more than 20 years in the chemical and pharmaceutical industry in Basel as head of laboratories, consultant and Qualified Person (QP). Armin is a lecturer and trainer in E&L at conferences and seminars and member of various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan). Armin is Chairperson of the Pharmacopeia expert group 16 in the European Directorate for Quality of Medicine (EDQM).

Julia Hupfeld

Cell & Gene Therapy Specialist – Strategic Account Management

Julia Hupfeld is Cell and Gene Therapy Specialist in the Strategic Account Management Team at Sartorius. She has been working at Sartorius since 2017 in different positions including R&D, Marketing and Sales, focusing on CGT applications.

Julia has worked in the CGT field since her PhD, which she obtained from the Technical University of Munich. She has several years of experience in process development for cell-based therapies from various industry positions.

Roberto Menzel

Manager of PD Global Extractables Lab FMT

Roberto Menzel has been working for Sartorius since 2015 where he is manager of the global Extractables Lab. He earned his Ph.D. in Chemistry from the University of Jena and started his career as an editor in the natural science book section at Wiley, followed by a position as group leader at an environmental analytical division at Eurofins Scientific. 

 His team is dedicated to performing extractables and material qualification studies for single-use systems, as well as providing interdisciplinary analytical services to support various Sartorius teams. He leads and advocates the company's E&L strategy with numerous scientific publications and by engaging with key customers, regulators, and industry consortia, such as BioPhorum. His team has been integral in developing the ExSim software, which streamlines E&L qualification for our customers. 