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Evènement :The Use of Design of Experiment and Design Space to Optimize your Immuno/Bioassays in Pharma/Biotech

Date :Vendredi 07 Décembre 2018

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--





All aspects of the drug development process, (pre-) clinical and manufacturing, are in need of reliable assays to demonstrate safety, efficacy and robust production. Bioassays are often demanding assays and tools to facilitate their development are needed. Design of Experiment and Quality by Design are two tools that can support the bioassay life cycle.  

Why should you Attend



  • Intro to DoE
  • Examples
  • Optimization/Validation
  • Design Space and Quality by Design 


Areas Covered in the Session



  • Introduction to DoE and QbD and how to use them to develop, optimize and validate your bioassays

Learning Objectives


  • Using DoE and QbD to make your bioassay life cycle more robust and efficient


Who Will Benefit



  • Anyone involved in biotech and pharma working with Assays, Regulatory, Quality Assurance 


Speaker Profile


Melody Sauerborn, by background an immunologist and virologist, literally stumbled into the world of biologics when entering her PhD. During her PhD she investigated the correlation between protein aggregates and immunogenicity in transgenic mouse models under the supervision of Prof. Huub Schellekens and Prof. Wim Jiskoot. The years following her PhD, Dr. Sauerborn expanded her experience in bioanalytical methods by working as a project leader, trainer and senior expert in CROs and biotech companies. 

Her expertise includes: set up and validation of immuno- and bioassays, immunogenicity, manufacturing (in specific potency assays) and all regulatory framework connected with it. She is experienced in GLP/GCP/GMP, and FDA, EMA, USP, EP and ICH guidelines with regards to small molecules, biologics and vaccines. Dr. Sauerborn also acts as an evaluator for the Swedish innovation agency, Vinnova, where she rates business proposals of start-up biotech companies competing for seed funding. 

As a freelancer and interim manager, Dr. Sauerborn enjoys the variety of her projects and is blessed with being able to share her experience by teaching workshops and webinars around the world.


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