Stephanie Knueppel, F. Hoffmann-La Roche AG - Qepler Summits And Conferences

Stephanie Knueppel

Stephanie Knueppel - Head of MSAT Cleaning, Decontamination and Product related Process Validation and Monitoring
F. Hoffmann-La Roche AG
Freiburg, Germany
Grüetzi and welcome to Roche in Switzerland. Get to know us.

Stephanie Knueppel graduated from the WWU University in Münster in 1996 in Chemistry. After receiving her Ph.D. in Organic Chemistry she joined Ciba Specialty Chemicals in the year 2000 as Manager in Process Development working on Development, Scale-up and optimization of complex chemical syntheses/production processes, Strategic project design, process transfer lead to local and global manufacturing sites and CMOs.

Since 2009 Stephanie joined F. Hoffmann-La Roche AG in Switzerland working in different departments with increasing responsibilities. In her current function as Head of MSAT Cleaning-, Decontamination- and Product related Process Validations and Monitoring in sterile drug product manufacturing Kaiseraugst, Stephanie is responsible for validation oversight & execution from conception to implementation to realization to documentation to life cycle management; support of Tech Transfers; ensuring compliance to cGMP, PQS and Health authority requirements. As well as Elaboration and Implementation of new technologies to support manufacturing and innovation needs.

Stephanie is honoree of the 2019 PDA Fred Simon Award for the paper “Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product - Hydrogen Peroxide Uptake and Impact on Protein Quality”

Related Sessions:

2nd Annual Highly Potent APIs
Summit 2020

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 19 Feb 2020
  • Prague, CZ
  • Pharma
Day 2: Thursday, 20 February 2020
CASE STUDY: Challenges of introducing an ADC into a multi-purpose Drug Product facility.
  • Cross Contamination Control Concept
  • Cleaning Validation and Monitoring Strategy
  • Deriving most stringent Acceptance criteria
  • Challenges in production routine
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