MONDAY, AUGUST 12 | 8:30 – 11:00 am
SC1: Optimizing Cell Culture Media
Jochen B. Sieck, PhD, MBA, Head, Perfusion Systems and Cell Culture Media R&D, Merck Life Science
To grow mammalian cells, researchers need to provide an optimal in vitro environment. The key feature of successful cell growth is the culture medium. ‘Achieving Super Soup’ requires finesse and know-how in order to combine the right ingredients at the right times under the right conditions to achieve high titers. This workshop will provide a foundation for optimizing cell culture media as well as a look at how media development is being innovated. Cell Culture Media experts will also tailor a portion of the course for interactive discussion per the concerns and challenges faced by workshop participants.
SC2: A Modern Approach to Biologics Formulation Development
Instructors: Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development and Biologics Manufacturing, AnaptysBio Inc.
Danny K. Chou, PharmD, PhD, President and Founder, Compassion BioSolution; Former Senior Research Scientist, Biologics Development, Gilead Sciences
This course offers a forum on how to develop sound formulations for biologic drugs. Case studies will be presented to demonstrate how to incorporate QbD concepts to do risk assessment, design multivariate experiments, and assess critical quality attributes including subvisible particle characterization in order to develop a robust formulation for the bulk drug substance or final drug product in the context of designated container closure systems. This course utilizes real-world examples and interactive discussion.
SC3: Quality Considerations for Gene Therapy Viral Vectors
Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.
Gene therapy viral vectors are complex biological medicinal products which pose a number of challenges with respect to quality and overall adventitious agent safety. Firstly, they are large complex viral particles which must be designed to be replication incompetent. Secondly, as the product is a suspension of viral particles, application of traditional viral reduction and elimination steps is not possible, so control of materials and the process become more important. This course outlines the testing expected to address these fundamental features and ensure a safe product of suitable quality is released.
SC4: AI-Celerating Bioprocess Information Research
Diana Bowley, PhD, Business Relationship Manager, R&D IR, AbbVie
Brian Martin, Senior Principal Data Scientist, Head of AI, R&D IR, AbbVie
As pharmaceutical research and discovery embarks into the increasingly complex world of biological entities beyond simple monoclonal antibodies, the already daunting landscape of complexity and cost in drug discovery and development expands to a nearly incomprehensible level. In order to work within this vast space, the use of machine learning and cognitive computing techniques is helping to amplify the power, hone the precision, and expand the scale of research by augmenting human capabilities.
SC5: Saving Time in Process Development with Next-Generation Methods: PAT, Hybrid Modeling, Process Simulation, mDoe and iDoE
Instructors: Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
Moritz von Stosch, PhD, Senior Manager, Drug Substance, Technical R&D, GSK Vaccines
In this short course, we show how a more accurate design space can be defined that provides increased flexibility for process operation based on the iDoE-hybrid modeling strategy. We also show how advanced monitoring strategies support the tracking of the deviations and how these methods can readily be developed from the iDoE data. It will be illustrated how the combination of the hybrid model with monitoring can directly be exploited for process control, thus naturally evolving the last step of the QbD roadmap.
TUESDAY, AUGUST 13 | 6:00 – 8:30 pm | dinner provided
SC6: Integrated Continuous Biomanufacturing – An Implementation Approach
Robert Dream, Managing Director, HDR Company Ltd.
The importance and value of continuous processing’s economic and sustainability advantages due to the modular nature of continuous processes means that the industry is able to adapt more rapidly to changing market demands. Factors other than scientific ones, are the barriers to change from batch to continuous production. The (bio)pharmaceutical industry has reached a stage that requires a change in the production paradigm. Continuous manufacturing is as productive and has a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. This course will cover strategies to transition from batch to continuous, areas to implement continuous manufacturing (from upstream to fill-finish), step-wise approach to implementation, new technologies and impact of big data, and more.
SC7: Protein Aggregation: Mechanism, Characterization and Consequences
Thomas Laue, PhD, Professor Emeritus, Molecular, Cellular and Biomedical Sciences, University of New Hampshire
Matthew Brown, PhD, Applications Manager, Bioscience, Malvern PANalytical
Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutics. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth course reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals. It benefits scientists engaged in the development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of protein aggregation.
SC8: Model-Based Solutions for Digitalization and Automation in Bioprocessing - What Data, Expertise and Software Do I Need?
Michael Sokolov, PhD, COO, DataHow, and Lecturer, ETH Zurich
The aim of this course is to provide an overview and advanced insight into process data characteristics and analysis methodologies. It will cover important perspectives on data organization and pretreatment, basic and advanced analysis methodologies and software solutions as well as central expertise and domain knowledge to be included into the assessment of process data. The course will combine an introduction into central concepts and their application to cases studies from industry. The goal is to reveal the large potential of data- and knowledge-driven solutions to create value from data in the bioprocessing domain.
SC9: Impact of Impurities on Stability of Biologics
Diane Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.
Katherine E. Bowers, PhD, Principal Scientist, Group Leader, Fujifilm Diosynth Biotechnologies
Impurities in protein therapeutics can originate from a variety of unexpected sources. As the protein molecule is taken through the upstream/downstream processes, final product manufacturing (fill/finish) and even during patient delivery, there is a myriad of potential “hidden” impurities that can have an impact to the safety and efficacy of the bio-therapeutic. This course aims to answer the questions of what and where are the greatest risks for biologic impurities and how can we study the impact of these impurities on the protein molecule. Our mission is to collectively discuss how to identify, evaluate and mitigate impurity risks from early development and throughout the product life cycle.
SC10: Phase-Appropriate Analytical and Process Control Strategies
Christine P. Chan, PhD, Principal Scientist, Global Manufacturing Science & Technology, Sanofi
Biotherapeutics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. The establishment of an integrated control strategy for robust manufacturing is an iterative process based on sound science and quality risk management. In this short course, we will discuss key considerations in evolving the analytical and process control strategies through the course of product development.
*Separate registration required