Dr. Andreas Nixdorf, SGS Institut Fresenius GmbH - Qepler Summits And Conferences

Dr. Andreas Nixdorf

Life Sciences - Business Development Manager Extractables & Leachables Testing
SGS Institut Fresenius GmbH
Frankfurt Am Main Area, Germany
SGS INSTITUT FRESENIUS gehört zu den führenden Anbietern für nicht-medizinische Laboranalytik in Europa. Unsere Kompetenz zeigt sich in mehr als 180 Zertifizierungen, Akkreditierungen und Zulassungen sowie in 155 Jahren Erfahrung im Analytikbereich.

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 PhD/doctorate in 1997, he worked in different scientific and managerial positions ranges from head of laboratory to GMP QA site manager in Life Science industry prior he proceeds 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 at SGS in 2008 and got his current position of an 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 pharmaceutical and medical industry.

With over 20 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 Industry 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.

Related Sessions:

Extractables & Leachables
Summit 2019

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 15 Oct 2019
  • Berlin, DE
  • Pharma
Day 2: Wednesday, 16 October 2019
CASE STUDY: Leachables strategies for finished biopharmaceuticals.

Extractables and leachables are product-related impurities that result from product contact with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes that are used for processing, storage, and/or delivery of biopharmaceuticals.

Leachables are of concern for patients due to potential effects on product quality and safety. It is possible that such an impurity could directly impact the patient or indirectly impact the patient by interacting with the protein by chemical reactions. Adducts and leachables may or may not be detected as product-related impurities in leachables screening stability studies depending on the rigor of the analytical program.

The need for the development of a thorough and holistic extractable and leachable program based on risk assessment, review of existing literature, and consolidation of industry best practices is discussed. Risk mitigation strategies for an extractable-leachable program must be divided into different stages. The integration of analytical activities with health-based risk-assessment information into the design of an extractable-leachable program is highlighted.

View Details

2nd Annual Extractables &
Leachables Summit 2020

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 22 Oct 2020
  • Virtual,
  • Pharma
Day 2: Friday, 23 October 2020
CASE STUDY: Leachable Study design Space in Complex formulated Drug Products such as Biopharmaceuticals.
  • Assessment factors that must be presented to the authority through the leachable study design
  • Assessment Robustness: Matrix Impacts, Large Volume problem and others
  • Strategic elements that can be incorporated into the study design: Simulation, Negative Controls, Aging Controls
View Details

3rd Annual Extractables &
Leachables Summit 2023

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 11 Oct 2023
  • Virtual,
  • Pharma
Day 1: Wednesday, 11 October 2023
CASE STUDY: To Be Announced
View Details