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PROGRAM CHAIRS:
Robert R. Boulanger, PhD - CRB
Jeffery N. Odum - NNE

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.

Gilad Langer, PhD
Director, Automation & MIS, NNE
Breaking Down the Walls – Integrated Process and
Automation Design with Concurrent Engineering

Abstract

Engineering and design of a pharmaceutical facility requires extensive collaboration and communication between many engineering disciplines. Yet in the pharma industry, it is still common practice to engineer and design in disciplinary silos. Compared to other industries, the pharma engineering practices are laggards from this perspective. Thirty years ago in the advent of the lean manufacturing movement, a similar observation brought about the concept of Concurrent Engineering. The observation was that performing engineering in silos where design was "tossed over the wall" between disciplines was inherently wasteful. Concurrent Engineering, sometimes also called Integrated Design, presents a method in which engineering activities are performed in parallel with simultaneous activities leading to a higher quality process design and a more effective engineering process. The benefits include the ability to achieve specific design goals such as flexibility, configurability for multi-product processes, discovering errors and redesigns early, integrated quality, more effective qualification, and much more. We are addressing a specific issue within our industry in which we are lagging behind. Concurrent Engineering practices have been around for over 30 years and yet we still have a practice of engineering in silos. We need to find a way to capitalize on the benefits of this well proven concept and make it the mainstream way to engineer and design facilities and processes starting with concurrently engineering the process and automation systems.

Biography

Dr. Gilad Langer is an accomplished business leader with broad technical knowledge and strategic perspective in the manufacturing systems domain. His experience spans over 25 years in different roles in complex engineering projects including project management, implementation, team building, strategy development, research, and support of mission critical operations. His experience spans a multitude of domains in the biopharmaceutical, pharmaceutical, life sciences, automotive and semi-conductor industries, including: manufacturing business systems (i.e. manufacturing execution systems [MES], manufacturing intelligence [MI/EMI], quality management systems [QMS], etc.) and interoperability with both automation and enterprise systems; all aspects of engineering and integration services operations, strategy, management and sales; as well as industrial and academic research by way of a doctorate degree focused on adopting the characteristics of social systems in software architectures for manufacturing systems. Specialties include manufacturing systems, MES, QMS, MI, manufacturing quality, lean manufacturing, manufacturing operation, software modeling, software development, product strategy, product management, product marketing, business analysis, strategic planning, business intelligence, business process interoperability, pragmatic marketing, agile management, and team building.

Sam Watts, PhD
Technical Business Development Officer, Stratophase Ltd.
Adaptive Process Control Techniques for Next Generation Biologics
and Biomanufacturing of the Future

Abstract

Biologics are becoming increasingly complex in terms of therapeutic properties and the conditions required to manufacture them. The diversifying pipelines within the biologics industry present a significant challenge during process development through into biomanufacturing. A game-changing solution to such challenges is the adoption of adaptive process control techniques, enabled by big data approaches to process characterization and next generation real-time monitoring and control technologies. Adaptive process control techniques enable processes to be dynamically tracked, and the process parameters required to maintain the quality of the process and product adjusted in real time. The ability to adapt to, and compensate for, in-process variation is of particular benefit to cell culture processes where subtle differences in the environment can have a profound effect on product yield and quality, both in terms of a single batch but also with respect to batch-to-batch consistency. Adaptive process control will also be essential for continuous manufacturing processes to become a reality in biomanufacturing. A review of the techniques and technologies being applied to adaptive process control will cover the application of ‘big data’ and real-time monitoring approaches, including; statistical techniques such as Design of Experiments (DOE) and Multivariate Data Analysis (MVA) used to generate greater process understanding during process development and into manufacturing; real-time monitoring techniques used to implement novel control strategies such as Raman spectroscopy, soft-sensors, and probing control. A number of case studies will be presented showing adaptive process control being applied to rapid cell culture optimization during process development, and dynamic feeding control for enabling complex and multi-component feeding strategies during upstream biomanufacturing. The emergence of adaptive process control techniques has the potential to minimise process development timelines and increase process robustness during manufacturing. These advanced control strategies are expected to have a profound impact on the manufacture of next generation biologics and are potentially enabling for the advanced therapies industry.

Biography

Sam is one of the co-founders of Stratophase Ltd., and is an engineer by background, with a B.Eng in Material Science and a PhD in Optoelectronics. He has broad experience developing technology for monitoring and control applications. He spent the last 10 years working closely with users of upstream bioprocesses in the global biopharmaceutical industry, and has developed significant expertise in the area of cell culture process and feeding strategy development. Sam’s current areas of interest include adaptive process control and the paradigm shift that such techniques can offer to biomanufacturing.

Yaling Shi, PhD
Senior Manager, Emerging Technology, Lonza Walkersville, Inc.
Automated Manufacturing Solutions for Patient-Scale Therapies

Abstract

Cell therapies have been in clinical development to attempt to treat an array of human diseases. Researchers around the globe are evaluating the effectiveness of cell therapy as a form of replacement or regeneration of cells for the treatment of numerous organ diseases or injuries. However, the current manufacturing costs of these therapies are too labor intensive and expensive. The commercialization of cell therapy processes will thus require automated and closed manufacturing processes which are cost effective, robust, and efficient. Octane Cocoon is an integrated manufacturing solution for all patient-scale therapies (Precision Medicine) in an automated, scalable, and closed system. Cocoon can not only be used for suspension cells such as CAR T-cells, but also for adherent cells such as mesenchymal stem cells (MSCs) and chondrocytes. This presentation will highlight both the CAR T and MSC process using Cocoon to maximize final product yield. We will also identify common bottlenecks and challenges in automated cell therapy design and explore potential solutions for the optimization of cell-based products.

Biography

Dr. Shi leads autologous cell therapy platform development at Lonza. She has a proven track record of developing cell-based technologies from concept, to scale-up, to commercialization, and through sales and marketing. She has commercialized two cellular products AlloStem® (a stem-cell based bone growth substitute for spinal fusion, non-union, and foot and ankle, etc.) and ProChondrix® (a chondrocytes-based live cartilage product).

William G. Whitford
Strategic Solutions Leader, BioProcess, Life Sciences, GE Healthcare
Developments in Digital Biomanufacturing

Abstract

The concept of digital biomanufacturing (DB) is changing the way we view biopharmaceutical manufacturing. Keys to this initiative include increased monitoring, connectivity, information integration, computing power, control algorithms, and automation. DB is part of an evolution: one further step in the application of such technologies as multiplexed reactor monitoring, industrial internet of things (IIoT), and cloud computing. Powerful algorithms employ disparate data from new sensors and at-line analytics, along with such other high value information as process history records, to better understand the current state of operations and provide advanced model-based process control. More than instruments becoming interconnected, DB denotes high levels of data analysis, information management, and dynamic simulation in a “process network”. Such initiatives support the implementation of such new manufacturing modes as continuous biomanufacturing and such new products as targeted exosomes. By this, manufacturers gain actionable intelligence, transformative insights, and more effective plant control. Supported by DB, EMS designs will move beyond highly automated to become nearly autonomous sources of centralized integrated control of the distributed pools of metadata in such arenas as supply chain, manufacturing process control, and customer relationship management.

Biography

Bill Whitford is the Strategic Solutions Leader at GE Healthcare in Logan, Utah with over 20 years' experience in biotechnology product and process development. He joined the company as an R&D leader developing products supporting protein, biological, and vaccine production in mammalian and invertebrate cell lines. Products he has commercialized include defined hybridoma and perfusion cell culture media, fed-batch supplements, and aqueous lipid dispersions. An invited lecturer at international conferences, Bill has published over 250 articles, book chapters, and patents in the bioproduction arena. He now enjoys such activities as serving on the Editorial Advisory Board for Bioprocess International and the European Medical Journal.

Marissa Nasshan
Director, Business Development US, Ovizio Imaging Systems NV/SA
In-Line, Automated Monitoring with Viral Detection, A Case Study

Abstract

Finding process analytical technology (PAT) solutions for in-line and automated cell culture monitoring during infection processes is now acheivable with the iLine F Monitoring System. In 2017, we conducted several experiments that resulted in viral load detection, offering an accurate read-out and percentage of infected cells alongside viability and density measurements. Pushing our proprietary software to new depths by recording 74 cellular parameters, we can now add viral detection and visualization of protein expression to the growing list of measured data.

Biography

Marissa Nasshan joined the Ovizio team in 2016. As the Director of Business Development, Marissa is the permanent presence and first point of contact to expand the Ovizio brand and line of products in the US. Marissa received a Bachelor’s and Master’s Degree in Cell and Molecular Biology from Central Connecticut State University. She gained six years of experience working for a company specializing in vaccine development and protein production, first as a Research Scientist in Upstream Process Development Cell Culture, and later as Manager of Commercial Operations. She then became Director of Operations for a privately held government research startup firm before joining Ovizio. Other experiences include molecular imaging, bioprocessing, commercialization, manufacturing, and marketing and sales. Outside of work Marissa is a Board Member for a non-profit organization that empowers young women to enter into professions in STEM.

Ravi Shankar
Life Science Industry Manager, Endress+Hauser Inc.
Continuous Process Verification — Asset Health and Performance

Abstract

Critical processes in the pharmaceutical and biosciences industries often require frequent calibration of temperature instrumentation to insure proper sterilization has occurred and there is no risk of cross contamination. In most cases the calibration cycle is a statistical calculation based upon the risk of excessive drift of the sensor occurring based upon an evaluation of risk vs. downtime, lost production, and the expense of conducting manual calibration. Recent developments in instrumentation simplify and promote greater calibration process efficiency, reduce the risk and need for frequent, unnecessary calibrations, and provide better reliability. This presentation will explore asset health and performance monitoring that gives reliable data on process impact factors related to corrosion, coating or build up, and entrained gas and present metrology-based techniques to verify measurement quality by a traceable and attested means.

Biography

Ravi Shankar is the Life Sciences Industry Manager at Endress+Hauser USA in Greenwood, Indiana. Based in the San Francisco Bay area, he joined Endress+Hauser in May 2011. He has worked with process instrumentation for 21 years and been associated with the life sciences industry for the last 13 years in various roles. He is also active with the ASME BPE subcommittee on process instrumentation as a member in developing guidelines for the industry. He holds a BE in instrumentation technology from Bangalore University, India. His interests include smart instrumentation and single use sensors and systems.

Matthew T. McRae
Biotechnology Product Line Manager, Nova Biomedical
Rapid Process Development for a Miniature-Scale Culture System
Sebastijan Peljhan, PhD
Product Manager and Technical Support, BIA Separations
Process Analytics for Gene Therapy Vector Production
Tod Canty
Engineer, JM Canty, Inc.
Novel Process Analytical Technology (PAT) Applications
Using Advanced Imaging Technology
Marc Pelletier, PhD
Director, Strategic Consulting, CRB
Mark F. Witcher, PhD
Senior Specialist, Process Operations,
Strategic Manufacturing Concept Group (SMCG), NNE


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