Ahead of this year's Extractables & Leachables Asia, we spoke with Dr Armin Hauk, Principal Scientist at Sartorius Stedim Biotech GmbH,​ learn more about what he shared with us below!






Q1 Dear Dr. Hauk, it’s our first time to have you in E&L Asia, we are really looking forward to hearing your presentation! Can you give us a bit of insight into what your will sharing at the conference ?

My presentation will show methods for the assessment of process equipment related leachables (PERLs) in the CGT area. This covers on one hand modelling approaches to calculate PERL exposure in CGT applications. This is valuable, because it is foreseeable that a measurement of a PERLs exposure in a CGT-process or leachables on therapeutic cells is challenging, if not impossible. The second part of my presentation analyses potential toxicological risks of PERLs in CGT. For this we collaborated with the May Planck Institute, where a modern high throughput cell painting assay is available, which can measure hundreds of cell features (“effects”) in one run. And – of course – I will share some results from modelling and the cell painting assay.

Q2 This topic has also been published on Nature, can you share the purpose of this research and what it will affect?

The purpose of the research was to get an impression about the potential risk, which is associated with PERLs in the CGT area. As out feasibility study was using a modern test system, the cell painting assay, and it was the first time that hundreds of potential effects of PERLs on isolated human cells was tested, we were able to publish it in Nature.

Q3 E&L studies involve complex matrices. What do you find is the most challenge part during your work at the moment?

The most challenging part of my work is to convince people to use good science for doing an E&L risk assessment. Today we often see people still using “worst case” assumptions and methods in E&L risk assessments. But honestly after more than 20 years of E&L our today available prior knowledge in chemistry, physics and biology allows to do much more than simple “worst case assessments”. Extractables can be predicted by using AI, PERL-exposure can be calculated with suitable models and toxicological data for hundreds of PERLs are already available. So we can really enter a new era of E&L assessment if we combine and use our prior knowledge.

Q4 What are you most looking forward to at E&L Asia?

I hope to find some interest on our approach to enter into the new era of E&L assessment, as this could simplify and speed up our work, make it more reliable and more sustainable.