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PROGRAM CHAIRS: PROGRAM CHAIRS: PROGRAM CHAIRS:
Jeri Ann Boose, PhD
Eurofins Lancaster Laboratories, Inc.
Robert R. Boulanger, PhD
CRB
Alissa M. Resch, PhD
Coriell Institute for Medical Research
Raymond Nims, PhD
RMC Pharmaceutical Solutions, Inc.
Jeffery N. Odum
NNE
Fang Tian, PhD
American Type Culture Collection (ATCC)






Christoph Herwig, PhD
Head Biochemical Engineering, Technische Universität Wien
Multi-Parametric Control Strategies for Enabling Continuous Biomanufacturing

Abstract

The goal of bioprocessing is to optimize process variables, such as product quantity and quality in a reproducible, scalable, and transferable manner. However, bioprocesses are highly complex. A large number of process parameters and raw material attributes exist, which are highly interactive and may vary from batch to batch. Those interactions need to be understood, and the source of variance must be identified and controlled. Currently, mechanistic models, which are based on mechanistic links and first principles, are the focus of development. They are perceived to allow transferability and scalability because mechanistics can be extrapolated. Moreover, the models deliver a large range of hardly measureable states and physiological parameters. Furthermore, models need to be deployed in the control context: bioprocesses need to be controlled on the one hand by different parameters simultaneously (e.g. constant precursor concentration and specific growth rate), and on the other hand may have different objective functions (maximum productivity and correct product quality). Hence, novel solutions and case studies for multiple input and output controls need to be developed, as they already exist in other market segments. The presentation will display current solutions and case studies of mechanistic model development and its deployment for multi-parametric control of bioprocesses. The following elements, for example, will be covered:
• Workflows: how mechanistic models can be developed and calibrated in terms of identifiability, sensitivity, and observability
• Models as process analytical technology (PAT) tools: demonstrations of cases in which models are a solution to measure less
• Observer solutions for real-time parameter optimization
• Multiparametric control and event prediction

Biography

Christoph Herwig, bioprocess engineer, graduated from the process engineering department, RWTH Aachen University in 1994. He worked in industry in the design and commissioning of large chemical facilities prior to entering his interdisciplinary PhD studies at the Swiss Federal Institute of Technology (EPFL), Lausanne, Switzerland in the field of bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and design of biopharmaceutical facilities through his work at different companies from process development and engineering services to biopharmaceutical production. Since 2008, he has been a full professor of biochemical engineering at the Vienna University of Technology (TU Wien). His research area focuses on the development of methods for integrated, science-based, and efficient bioprocess development along PAT and QbD principles. The product fields are circular economy and biopharmaceuticals within industry-driven projects.

Marcin Łoś, PhD, DSc
Chief Executive Officer, Phage Consultants
An Arms Race Between Bacteria and Bacteriophages — Will This War Ever End?
Nathan J. Roth, PhD
Director Pathogen Safety, Global R&D, CSL Behring
Todd L. Talarico, PhD
Vice President of Manufacturing and Process Development, Medicago USA
Demetri Petrides, PhD
President, Intelligen, Inc.
Rosemary J. Versteegen, PhD
Chief Executive Officer, International Serum Industry Association (ISIA)
S. Steve Zhou, PhD
Director, Virology and Molecular Biology, MicroBioTest, div. of Microbac Laboratories, Inc.
Donald L. Jarvis, PhD
President, GlycoBac LLC
Sebastijan Peljhan, PhD
Product Manager and Technical Support , BIA Separations


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Web: www.isbiotech.org • Email: [email protected]