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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.

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.

Jamie Almeida
Research Biologist, Biochemical Science Division, Bioassay Methods Group
National Institute of Standards & Technology (NIST)
Mouse Cell Line Authentication Consortium Update

Abstract

Misidentified and contaminated cell lines continue to persist in the scientific community. Standard methods are in place for human cell line authentication; however, standards for non-human cell lines are lacking. NIST has partnered with ATCC to validate short tandem repeat (STR) markers developed at NIST for identity testing of mouse cell lines by establishing the Mouse Cell Line Authentication Consortium. This is a collaboration between 13 labs and involves an interlaboratory study to test 50 of the most commonly found mouse cell lines using 19 mouse STR markers. The consortium members were provided a kit containing a master mix, multiplex primers, mouse DNA, a human control, and calibrants. PCR will be used to amplify the target STR markers and these amplicons will be separated using capillary electrophoresis. Each lab will process the samples based on the instrumentation found in their labs which include various models of fragment analyzers, different arrays, and polymers. The fragment analysis data will be analyzed using various software platforms and submitted to NIST upon completion. The results from this consortium will lead to the development of a public STR database for mouse cell lines, and ultimately a written consensus standard for mouse cell line authentication.

Biography

Jamie Almeida received a Bachelor of Science in Microbiology from Arizona State University and a Master of Science in Biotechnology with a concentration in Biodefense from the Johns Hopkins University. She has worked at NIST since 2004 in the Bioassay Methods Group, part of the Biosystems and Biomaterials Division. Some of her past contributions include: 1) stability studies for B. anthracis Sterne spores, 2) development of a rapid bioassay test for ricin using a GFP expressing cell line, and 3) decontamination of various biothreat agents in water systems in the presence and absence of pipe biofilms. Jamie has worked closely with the DNA forensics group at NIST since 2010 learning to separate short tandem repeat alleles using capillary electrophoresis and optimizing multiplex PCR assays. Using this knowledge, she has focused her efforts on the identification of non-human cell lines, specifically monkey, mouse, hamster, and rat.

Rosemary J. Versteegen, PhD
Chief Executive Officer, International Serum Industry Association (ISIA)
New Testing and Treatment Methods for Animal Sera
S. Steve Zhou, PhD
Director, Virology and Molecular Biology, MicroBioTest, div. of Microbac Laboratories, Inc.
Heat Inactivation of Virus: Expect the “Unexpected”
Marcin Łoś, PhD, DSc
Chief Executive Officer, Phage Consultants
An Arms Race Between Bacteria and Bacteriophages — Will This War Ever End?
Matthew T. McRae
Biotechnology Product Line Manager, Nova Biomedical
Rapid Process Development for a Miniature-Scale Culture System
Donald L. Jarvis, PhD
President, GlycoBac LLC
Virus-Free Insect Cell Lines for Baculovirus-Mediated Recombinant Protein Production
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.
Sebastijan Peljhan, PhD
Product Manager and Technical Support, BIA Separations
Antonio J. Scatena
Sr. Sales Representative, Gateway Analytical LLC
Houman Dehghani, PhD
Director, Cellular Resources, Amgen Inc.
John M. Baust, PhD
President and Lead Scientist, CPSI Biotech
James Clinton, PhD
Scientist, ATCC Cell Systems, American Type Culture Collection (ATCC)
Douglas Storts, PhD
Head of Research, Nucleid Acid Technologies, Promega Corporation
Yvonne A. Reid, PhD
Consultant
Joaquina Mascarenhas, PhD
Senior R&D Scientist/Team Lead, MilliporeSigma
Lisa V. Kalman, PhD
Senior Advisor for Repository Science, Laboratory Research and Evaluation Branch
Centers for Disease Control & Prevention (CDC)
Nahid Turan, PhD
Director, Laboratory Operations, Coriell Institute for Medical Research
Paula Keskula
Operations Leader for the Cell Line Factory, Broad Institute
Fang Tian, PhD
Lead Scientist, Cell Biology Group Leader, ATCC Cell Systems
American Type Culture Collection (ATCC)


International Society for BioProcess Technology
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Web: www.isbiotech.org • Email: [email protected]