The Proper Use of Extractables Data – Aspects Beyond Extractables Measurement

The Proper Use of Extractables Data —
Aspects Beyond Extractables Measurement

Please join us for this Ask the Expert webcast.

Just fill out the form below to register.

Presenters:

Dr. Armin Hauk,
Lead Scientist at Sartorius Stedim Biotech GmbH

After his PhD, Armin started his career at Ciba-Geigy in 1995. He was responsible for the GLP & GMP lab for organic analysis, migration studies, Extractables & Leachables (E&L) investigations, development of GMP QC methods and stability testing. After 2010 Armin worked as consultant and Qualified Person (QP) for Intertek. Since 2016 Armin has a position at Sartorius-Stedim Biotech as Lead Scientist. Armin is lecturer and trainer in E&L conferences and seminars and he is member of PDA, ELSIE and the BPOG supplier group. Armin is delegate of the German BfArM in the Pharmacopeia expert group of the European Directorate for the Quality of Medicines (EDQM).

Jean-Marc Cappia,
Head of Segment Marketing, Vaccines at Sartorius Stedim Biotech GmbH

Jean-Marc Cappia is the Head of Segment Marketing Vaccines, at Sartorius Stedim Biotech based in Aubagne, France. With a Biotechnology Engineer graduation of the INSA of Toulouse and 30 years of experience, Jean-Marc supports the biopharmaceutical industry on a world-wide basis, in particular in process design, validation, training and implementation of single-use technologies. Jean-Marc is the author and co-author of more than 50 scientific papers, book chapters, patents and conference papers on sterilization, integrity testing, extractables & leachables and process validation.

About this event:

May 9, 2019

11 am EDT | 8 am PDT |
5 pm CEST

The implementation and use of single-use system (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond “simple” extractables measurement. In this presentation, we will show how we employed our experiences to come to a deep understanding of extractables, and finally to methods to predict extractables and leachables. We will show that only an adequate physical and chemical understanding allows a correct scaling and combination of extractables data for the numerous devices and assemblies provided to the market. And we will show how a mechanistic modelling, which combines sources and sinks of leachables appropriately can be used in risk assessments to quantitatively predict leachables along a process chain.