Christoph HERWIG. : Jenbachgasse 73/2, A-1130 Vienna (Mobile): (Office):

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1 Christoph HERWIG : Jenbachgasse 73/2, A-1130 Vienna (Mobile): (Office): Christoph.Herwig@tuwien.ac.at Personal Data Date of birth: May 19 th, 1969 Nationality: German Civil Status: Married Language abilities: German (mother tongue) English (fluent) French (fluent) Turkish (good) Main Areas of Expertise Extensive research experience in quantification, error detection, and identification of bio-process performance, including application of novel techniques for on-line monitoring & control. Comprehensive research understanding in microbial physiology and strain characterization tasks using dynamic process conditions. Thorough experience in managing complex engineering projects with up to 40 team members inside functionality, time and cost in biopharmaceutical industry Strong analytical and leadership skills. Academic Background July 2008 to date Vienna University of Technology Institute of Chemical Engineering Vienna, Austria FULL PROFESSOR (Univ. Prof.) Head of Research Division Biochemical Engineering Bioprocess Development along PAT and QbD principles. Development of methods for efficient and scienced-based bioprocess development Method development for converting data to information and further to knowledge Assuring scalability of the developed process Involving Disposable Technologies already in Process development for smooth transfer to manufacturing Head of 25 scientists Invested about 1.3 M Euro in equipment July 1997 to November 2001 Swiss Federal Institute of Technology Lausanne (EPFL) Laboratory of Chemical and Biochemical Engineering Lausanne, Switzerland DR. SC. TECHN. (in Bioprocess Engineering) Title: On-line exploitation tools for the quantitative analysis of metabolic regulations in microbial cultures Director: Prof.-Dr. Urs von Stockar CV of Christoph Herwig October 2011 Page 1 / 5

2 Ph.D. content Set-up of high-sophisticated bio-process environment containing multiple state of the art on-line sensors and automated by process management systems, including spectroscopic techniques, such as FTIR and Raman. Developed and implemented methods for the consistent on-line quantification of growth stoichiometry in dynamic process conditions and detection of gross error measurements. Developed software modules up to stage of industrial maturity Developed stoichiometric metabolic flux and kinetic models for elucidation of the cellular adaptation in transient growth conditions. Investigated transient physiology in S. cerevisiae, P. pastoris and Escherichia Coli, e.g. carbon catabolic repression, overflow metabolism, variability in biomass composition. Established scientific collaborations with industry, start-up enterprises and academia including preparation of successful grant application (CTI) to the Swiss National Science Foundation. Coordinated and implemented several short-term projects with industry and academia, such as EU-project on Engineering Yeast Starvation BIO Initiated launch of entrepreneurial activities in bioprocess optimization for Inotech Encapsulation AG, Dottikon. March 2001 June 2001 October 1989 to October 1994 October 1991 to June 1993 Swiss Federal Institute of Technology Lausanne (EPFL) The Branco Weiss Chair for Entrepreneurship & Innovation Lausanne, Switzerland ENTREPRENEURSHIP COURSE Intensive course for business related disciplines for entrepreneurs Rheinisch-Westfälische Technische Hochschule Aachen (RWTH) Aachen, Germany DIPLOM-INGENIEUR IN MECHANICAL ENGINEERING Field of specialization: Process Engineering Focused on membrane separation technologies for down stream processing. Conducted diploma thesis at the University College London, UK, Institute for Chemical and Biochemical Engineering Simulation of Gas Permeation processes. Rheinisch-Westfälische Technische Hochschule Aachen (RWTH) Aachen, Germany STUDIES IN BUSINESS ADMINISTRATION CV of Christoph Herwig October 2011 Page 2 / 5

3 Professional Experience December 2006 to June 2008 LSMW GmbH Allschwil, Switzerland Office Head for Engineering, Compliance and Validation Responsible for a group of up to 20 engineers as service provider for engineering and qualification in pharmaceutical projects Responsible for budget, profit, marketing, networking and development of the group Build up a group from 5-20 engineers with disciplinary lead and ensured occupation Acquired projects, mainly for biopharmaceutical facilities Managed projects, e.g. as general planner for a new biopharma investment project within functionality time and cost June 2004 to Nov 2006 February 2002 to May 2004 Lonza AG Visp, Switzerland LEAD PROCESS ENGINEER BIOPHARMACEUTICALS Responsible for engineering in large investment Biopharma projects In charge of implementation and scale up of biopharmaceutical processes in multi-product facilities, with detailed insight in a wide range of current and future industrial biopharmaceutical processes Lead Process Engineer for small scale cgmp bio pharmaceutical plant based on microorganisms (400 L including entire DSP) with responsibility for functionality, time and costs Lead Process Engineer for large scale cgmp bio pharmaceutical plant based on microorganisms (Two Trains 15 m3 including entire DSP) with responsibility for functionality, time and costs (35 MEuro own budget) Took over lead for logistics engineering in above project Successfully coordinated up to 40 team member in a large scale biopharma investment project within functionality time and cost Led decision taking in regulatory and GMP aspects, such as room classifications, material & personnel flows, HVAC design and room finishes and successfully defended plant design in front of FDA, Washington, Sept 2005 Responsible for implementation of PAT ( Process Analytical Technology) in bioprocess development for biopharmaceuticals Active member of the International Society of Pharmaceutical Engineering (ISPE) Pharmaplan Engineering AG Basel, Switzerland PROJECT MANAGER Responsible for the launch of the business unit biotechnology Successfully initiated project acquisition Executed consultancy services in bioprocess identification for pharmaceutical industry Disciplinary and organizational lead of a engineer group Project management and execution of qualification and validation projects for various unit operations in pharmaceutical industry Defined regulatory requirements and GMP standards Planned and executed FAT, DQ, IQ, OQ-tests CV of Christoph Herwig October 2011 Page 3 / 5

4 Head of the process engineering group for a large scale multi-purpose biopharmaceutical manufacturing project, LONZA AG, Visp Established time & motion simulation for bottleneck identification using Aspen BatchPlus In charge of the conceptual and basic process engineering for a grass root 120 Mio CHF project Responsible for functionality time and cost for the generation of engineering documents; e.g. P&I diagrams, equipment specifications, functional specification, etc. Interact with sections automation, construction, quality assurance, etc. Took over technical project engineering lead for a biopharmaceutical plant at 1000 l scale Coordinated and executed detail engineering, commissioning and qualification activities Theoretical and practical training for operating personnel November 1998 to February 2003 November 1994 to June 1997 Part Time Freelance CONSULTANT for Uhde GmbH In charge of commissioning of large scale conversion plant in India. CONSULTANT for Lurgi Life Science GmbH Supported commissioning of biotechnological plants N.N. Developed industrially mature concepts for quantification & control of cell culture fed-batch processes with multiple industrial partners Uhde GmbH Dortmund, Germany PROCESS ENGINEER Carried out all stages of design and commissioning phases of large scale plants using membrane electrolysis technology Carried out all major activities in Basic and Detail Engineering. Managed basic engineering activities for projects in Asia. Developed process simulation for the complete process using AspenPlus and integrated it in engineering activities. Carried out training for plant engineers, e.g. in India and Saudi Arabia. Assisted in commissioning of grass root plant at Naya Nangal, Punjab, India. In charge of commissioning of grass root plant at Veraval, Gujarat, India (5 months). CV of Christoph Herwig October 2011 Page 4 / 5

5 Scientific Contributions Relevant peer reviewed Publications (extract): Herwig, C On-line exploitation tools for the quantitative analysis of metabolic regulations in microbial cultures, Ph.D. thesis, Chemical and Biochemical Engineering, Swiss Federal Institute of Technology Lausanne, pp ISBN Herwig, C, Doerries, C, Marison, IW, von Stockar, U Quantitative analysis of the regulatory scheme of invertase expression in S. cerevisiae. Biotechnol. Bioeng. 76: Herwig, C, Marison, IW, von Stockar, U On-line stoichiometry and identification of metabolic state in dynamic process conditions. Biotechnol. Bioeng. 75: Herwig, C, Chetreanu, F, Niederberger, P, Marison, IW, von Stockar, U Quantitative analysis of the impact of HXK2 and REG1 deletion in Saccharomyces cerevisiae on invertase expression and respiration. Enz. Microb. Tech. 31: (Collaboration with Nestlé Research Centre) Herwig, C, von Stockar, U Quantitative analysis of the oxidative metabolism in HXK2 and REG1 deletion mutants of S. cerevisiae. Enz. Microb. Tech. 31: Herwig, C, von Stockar, U A small metabolic flux model to identify transient metabolic regulations in S. cerevisiae. Bioprocess Biosyst. Eng. 24: Herwig, C, von Stockar, U Quantitative comparison of transient growth of S. cerevisiae, S. kluyveri and K. lactis. Biotechnol. Bioeng. 81: (Collaboration with J. Nielsen, DTU) Jobe, AM, Herwig, C, Surzyn, M, Walker, B, Marison, I, von Stockar, U A generally applicable fed-batch culture concept based on the detection of metabolic state by on-line balancing. Biotechnol. Bioeng von Stockar, U, Valentinotti, S, Marison, I, Cannizzaro, C, Herwig, C Know-how and know-why in biochemical engineering. Biotechnology Advances. 21: Hoeks, FWJMM, Schmidhalter, DR, Gloeckler, R, Herwig, C, Theriault, K, Fire, S, van den Broek, W, Laukel, F BPMSS Lonza s Biopharmaceutical Small Scale Plant Started cgmp Manufacturing in September 2004 CHIMIA 59: Herwig. C, Process analytical technology in biotechnology. Chemie Ingenieur Technik (2010), 82, (4), Wechselberger, P., Seifert A. and C. Herwig. (2010). "PAT method to gather bioprocess parameters in real time using simple input variables and first principle relationships." Chem. Eng. Sc. 65: Dietzsch, C., Spadiut O. and C. Herwig. (2011). "A dynamic method based on the specific substrate uptake rate to set up a feeding strategy for Pichia pastoris." Microb. Cell Fact. 10(1): 14. Jazini, M. and C. Herwig (2011). "Effect of post-induction substrate oscillation on recombinant alkaline phosphatase production expressed in Escherichia coli." Journal of Bioscience and Bioengineering, accepted. Wechselberger, P. and C. Herwig (2011). "Model-based analysis on the relationship of signal quality to real-time extraction of information in bioprocesses." Biotechnology Progress, accepted. Rittmann, S. and C. Herwig (2011). Quantitative analysis of media dilution rate effects on Methanothermobacter marburgiensis grown in continuous culture on H2 and CO2." Biomass and Bioenergy, accepted. Book Chapters Herwig, C. (2011). The Analytical Challenge in QbD- from Data to Information and to Knowledge-from (Bioprocess) Development to Manufacturing. Quality by design - Putting Theory into Practice. S. Schmitt, DHI / PDA: Vienna, October 2011 CV of Christoph Herwig October 2011 Page 5 / 5