Dr. Simone Biel, Merck Millipore - Qepler Summits And Conferences

Dr. Simone Biel

Field Marketing Single Use Technology
Merck Millipore
Schwalbach am Taunus, Germany
Merck offers chemicals for applications in laboratories and industry. Biosciences, biopharma, food, cosmetics, LCDs, pharmaceuticals, printing, plastics and coating

Simone Biel is Field Marketing consultant of Merck Life Science’s single-use business.

In her role she investigates the market needs and trends of single-use technology used in final filling or other process application to ensure product performance meets all quality and regulatory requirements.

Simone joined Merck in 2006 to support the implementation of single-use systems in customer’s manufacturing processes. With this experience she acts as a subject matter expert to align Merck’s single-use systems and E&L strategy with drug manufacturer’s expectations.

Simone holds a PhD from the University of Frankfurt in Microbiology. She is an active member of the BPSA European Advisory Council.

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 1: Tuesday, 15 October 2019
BLOCK:
CASE STUDY: USP <665> draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems.

USP <665> draft will be the first standard for characterization of specifically single-use systems (SUS) used in manufacturing. In this session we will discuss:

  • Risk assessment with respect to patient safety to assign a risk level
  • Risk level appropriate testing of components
  • Approach for compliance for filters and SUS from a SUS supplier’s perspective
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