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Live Event

Extractables and Leachables

  • 29th September 2020
  • Webex flag Webex

In the course of this E&L Live Event, we will explore the guideline updates, analytical testing innovations, and the impact of Extractables and Leachables (E&L) on biologics safety. 

Let’s address the current E&L challenges with experienced pharmaceutical professionals who will share their in-depth knowledge on various topics.  

Join us on Tuesday, September 29th, 2020, at 1:30 p.m., and learn how to manage your E&L strategy and analyze testing techniques. 

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About Extractables and Leachables Event 

In the course of this E&L Live Event, we will explore the guideline updates, analytical testing innovations, and the impact of Extractables and Leachables (E&L) on biologics safety. 

Let’s address the current E&L challenges with experienced pharmaceutical professionals who will share their in-depth knowledge on various topics.  

Join us on Tuesday, September 29th, 2020, at 1:30 p.m., and learn how to manage your E&L strategy and analyze testing techniques. 

Request the brochure for more information.

Who Should Attend 

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists, Engineers and Fellows specializing in:

  • Bioprocessing
  • Container Development
  • CMC
  • Device Engineering
  • Extractables and Leachables/E&L
  • Formulation
  • Materials Science
  • Materials Selection
  • Manufacturing Science and Technology
  • Medical Devices
  • Parenterals
  • Packaging and Labelling
  • Product and Process Development
  • Pharmaceutical Analysis
  • QA/QC
  • Regulatory Affairs
  • Safety Assessments
  • Standardisation
  • Testing
  • Toxicology

Industry

  • Pharmaceuticals
  • Biotechnology
  • Medical Devices

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • Latest technological developments
  • Regulatory landscape and requirements for E&L studies
  • E&L guidance on medical devices
  • Toxicological risk assessment of E&L
  • Biomanufacturing

Dr. Simone Biel, DE

Regulatory Expert – Bioprocessing / Life Science | Quality and Regulatory Management

Merck KGaA

Simone is a Regulatory Expert at Merck Life Science and provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on Single-Use Technology (SUT). Over the last years, Simone supported biopharmaceutical drug manufacturer’s implementation of SUT in their manufacturing process.

With her deep understanding of SUT market needs and industry trends, she acts as a subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in Microbiology. 

Irene Cecchini, IT

Principal Scientist

Merck KGaA 

Irene Cecchini works as Principal Scientist in Merck Biotech Product Development division based in Guidonia Site, close to Rome - Italy. She graduated in Analytical Chemistry at the University of Rome in 2003 and joined former Serono as an analytical methods development junior researcher in the same year. In the following years, she developed her expertise, particularly in Extractables & Leachables (E&L), elemental impurities, and sub-visible particles (SbVP) fields.

In 2016 she was appointed Lab Manager of the E&L group, where she managed E&L studies on the final biotech products containers, as well as for manufacturing processes materials (Single Use Systems) and coordinated analytical investigations linked to manufacturing processes issues. Starting June 2019, she has been appointed Principal Scientist in the Impurity Analytics Unit of Analytical Development Biotech Department dealing with chemical and biological process impurities. She is a member of ELSIE, BPOG, and SbVP industry consortia.

DR. ARMIN HAUK, DE

Principal Scientist Extractables & Leachables

Sartorius Stedim Biotech GmbH

Armin started his career at Ciba in 1995. He was responsible for the GLP & GMP lab for organic analysis, migration studies, E&L investigations, development of GMP QC methods, and stability testing. After 2010 Armin worked as a consultant and Qualified Person (QP) for Intertek C&P in Basel. Since 2016 Armin has a position at Sartorius as Principal Scientist.

Armin is a lecturer and trainer in E&L conferences and seminars, and he is a member of ELSIE- and the BPOG-supplier group. Armin is German delegate in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM).

Dr. Reinhard Stidl, AT

Senior Toxicologist

Safetree Consulting e.U.

Dr. Reinhard Stidl is Managing Director of the independent consultancy office Safetree Consulting e.U., founded in 2018. Reinhard holds a Master in Chemistry (University of Vienna, 2002), a PhD in Chemistry (University of Vienna, 2007), a Master of Advanced Studies Toxicology (Medical University of Vienna, 2007) and is EUROTOX registered toxicologist (ERT) since 2011. Before working as a consultant, he gained more than 10 years of experience as a Toxicological Risk Assessor and team leader at Baxter, Baxalta, and Shire, where his last assignment was Associate Director Toxicological Risk Assessments.

 Dr. Stidl is an internationally known expert in chemical safety assessment in the context of pharmaceuticals since 2010, with a strong focus on extractables and leachables (E&L). During the assignments in the pharmaceutical industry, he was responsible for the global design and refinement of the global safety assessment strategy within Baxter, Baxalta, and Shire. Today, he provides his expertise to clients around the world, assisting in making pharmaceutical and medical products safe for patients.

DR. ANDREAS NIXDORF, DE

Business Development Manager Extractables & Leachables Testing

SGS Life Science Services

Andreas studied organic chemistry at the University of Bielefeld in Germany, with the main focus on mass spectrometry and computational chemistry. Since the date of his Ph.D./doctorate in 1997, he worked in different scientific and managerial positions, ranging from the head of a laboratory to GMP QA site manager in the Life Science industry, prior to proceeding with his carrier at SGS in 2007. From 2007 to 2010 he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got his current position as a business development manager in 2010.

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address solutions for a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from the pharmaceutical and medical industry.

With over 25 years’ experience in Life Science segment, he is a frequent speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del Farmaco in Pavia and others) in the fields of Medical Device, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory controlled industries are challenged by on-going regulatory systems. Changes must be set in practice, and cross-functional teams with different functional expertise must be organized to work toward a common goal.

Andreas wants to motivate experts from Life industries or organizations working together to realize or achieve a better and effective cross-departmental collaboration in order to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Dr. Michael Jahn, CH

Group Head Forensic Chemistry

Lonza

Dr. Michael Jahn is leading Forensic Chemistry at Lonza’s Drug Product Services in Basel, Switzerland. In the eleven years prior to this (Ciba Expert Services, Novartis), Michael was setting up and leading analytical laboratories that spe­cialized in trace analysis and structure elucidation with a strong focus on E&L testing. For Novartis Biologics, Michael was implementing this strategy for E&L assessment of all manufacturing, storage, and administration materials, with this contributing to numerous INDs/IMPDs and BLAs. In his current position, Michael uses his extensive analytical and regulatory knowledge on the topic of E&L to support Lonza’s customers from the (Bio) Pharmaceutical Industry.

Dr. Simone Biel, DE

Regulatory Expert – Bioprocessing / Life Science | Quality and Regulatory Management

Merck KGaA

Irene Cecchini, IT

Principal Scientist

Merck KGaA 

DR. ARMIN HAUK, DE

Principal Scientist Extractables & Leachables

Sartorius Stedim Biotech GmbH

Dr. Reinhard Stidl, AT

Senior Toxicologist

Safetree Consulting e.U.

DR. ANDREAS NIXDORF, DE

Business Development Manager Extractables & Leachables Testing

SGS Life Science Services

Dr. Michael Jahn, CH

Group Head Forensic Chemistry

Lonza

What our
participants
are saying

“I absolutely enjoyed the meeting with such a focused topic”

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Brinda Mahadevan

Director, Global Pre-clinical Development at Abbott Laboratories

Well organised and thoroughly enjoyed. All presentations were excellent!

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Live Event

Attendee

“Thanks a lot for all your organization which made this summit a real success.”

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Simone Carrara

E&L Laboratory Manager at Eurofins Biopharma Product Testing Italy