Quality by Design Handbook

Professor Christoph Herwig is a bioprocess engineer, graduating from the process engineering department, University of Technology RWTH Aachen in 1994. He worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at the University of Technology, EPFL, Lausanne Switzerland in the field of bioprocess identification. Subsequently, he positioned himself at the interface between bioprocess development and facility design of biopharmaceutical facilities working in different companies from process development over engineering services to biopharmaceutical production. Since 2008, he has been a full professor for biochemical engineering at the Vienna University of Technology. His research areas focus on the development of method of science-based and efficient bioprocess development along PAT and QbD principles. The product fields are renewable energy and biopharmaceuticals within industry-driven projects. Professor Jose Menezes is a professor at the Technical University of Lisbon (IST) and a senior researcher at the Institute of Biotechnology and Bioengineering (IBB) in Portugal. He coordinates a biosystems engineering lab within the Centre for Biological and Chemical Engineering, working in bioprocess development and bioengineering with PAT, chemometrics and multivariate statistics for over 10 years. He has a chemical engineering degree, an MSc in Catalysis and a PhD in Biochemical Engineering all from IST, and a Post- Doc in advanced monitoring of bioprocesses taken in industry. Since March 2009 he has been invited associate professor at The Faculty of Pharmacy in Lisbon University (FPLU). Jose is founder and adjunct-coordinator of a Masters Program in Pharmaceutical Engineering jointly offered by IST and FPLU, covering PAT/QbD disciplines such as chemometrics, DOE, NIR and multivariate monitoring, modeling and statistical process control techniques. He is a member of several international organizations, European editor of Journal of Process Analytical Technology and member of the editorial board of Chemometrics and Intelligent Laboratory Systems. Jose has published extensively.

• Quality by Design: an overview; Product design; Pharmaceutical process design; Biopharmaceutical process design; A systems view of pharma and biopharma; Extracting process knowledge (capturing process/product knowledge); Multivariate process modeling multivariate data analysis (PCA); Process analytical technology principles and aims; Risk-assessment: defining the topology of the 'map'; Design of experiments; Control strategies; Continuous improvement: process/product life-cycle management; Outlook and impacts; Case-Studies: PBL.