Day Two (14th May 2025) - CET/CEST (Cent Europe Summer, GMT+2)
- Geoffrey Pot - General Manager Operations, Site Head, Takeda
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
- Gearóid Duane - Principal Scientist, Manufacturing Science & Technology Upstream, Bristol Myers Squibb, Cruiserath Biologics
Spotlight Presentation – Calling all Technology Thought Leaders!
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Although commercially successful, cell-based production of therapeutic proteins is a costly, low-yield manufacturing process. CHO cell genome-scale metabolic models (GEM) hold promise for increasing cell line and culture efficiency thanks to their ability to predict whole cell metabolism and protein secretion in silico. This talk will present a collection of GEM-informed methodologies for CHO cell metabolic engineering at the genetic and process levels. Designed strategies have been comprehensively experimentally validated in house, demonstrating statistically significant improvements in product titres.
- Cleo Kontoravdi - Professor, Imperial College London
- Rui Manuel Freitas Oliveira - Associate Professor of Chemical and Biochemical Engineering, School of Science and Engineering Universidade Nova de Lisboa
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
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Novartis is driven by the goal of delivering high-quality medicines to patients worldwide. We have pioneered a continuous and connected biomanufacturing setup, operational in both non-GMP and GMP environments to streamline technology transfer. This innovative approach, designed for high efficiency, aims to significantly reduce costs and enhance sustainability.
This talk will showcase the evolution of a continuous processing project from development to GMP production. Besides looking at the current achievements and considering the knowledge acquisitioned over time, it also allows to look ahead how Novartis aims to further push the limits of biomanufacturing by exploring cutting-edge technologies and innovative process steps.
We will present new ideas that promise to elevate productivity, enhance process robustness, further reduce manufacturing costs and demonstrate that process intensification has untapped potential supporting Novartis to further remain at the forefront of continuous biomanufacturing.
- Julian Hitzler - Senior Expert Science & Technology, Drug Substance Development, Novartis Pharma
Choosing the Right Strategy: Factors to Consider Based on Your Production Process
- Multi-column chromatography
- Process intensification
Increasing capacity while maintaining product quality
Real-world examples: demonstrating increased capacity and product quality
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Hans-Rainer Voelger - Senior Scientist, Roche Diagnostics GmbH
State-of-the-art biopharmaceutical product development following quality-by design principles requires informed decision making to identify optimal process parameters and conditions as well as optimal input materials like chromatography resins or excipients for scale-up and technology transfer to manufacturing. To shorten process and formulation development timelines, it is key to also streamline delivery and availability of analytical data. We showcase an innovative analytical concept which enables for E2E automated analytical workflows of key assays including intelligent and dynamic decision making in real-time. Physical automation approaches are complemented by digital tools that improve data structure, quality and workflow efficiency.
A closed loop experimentation approach combining downstream process development and analytical work modules facilitates advanced biopharmaceutical product development in an innovative way.
- Petra Sebastian - Senior Scientist, Biopharmaceutical Product Development Bioanalytical Sciences, CSL Innovation GmbH
Spotlight Presentation – Calling all Technology Thought Leaders!
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Overcoming the hurdles of viral vector production:
- Low transfection efficiency
- Scalability issues
Strategies and tools to optimize production for viral vectors, such as:
- Novel reagents
- Improved innovative bioreactor design
Advanced analytics to optimize vector production
Utilizing the above for successful scale-up and improvements for efficiency
- Kyle Grant - Director of Vector Production, Voyager Therapeutics
Limitations of viral vectors & need for alternatives
Emerging non-viral delivery tech:
- LNPs, exosomes, CPPs
How novel approaches/systems can aid in:
- Safety, reduced immunogenicity, larger payloads
Utilizing new systems for existing pipelines
Analytical challenges associated with characterisation and ensuring the safety/efficacy of non-viral delivery systems
- Bernd Giebel - Founder & CTO, Exosla Therapeutics
- Lior Shaltiel - CEO, NurExone Biologic
- David Kuntin - CEO, Mesenbio
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
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- Veronique Chotteau, PhD - Professor Mammalian Cell-based Bioprocess Technology, KTH - Royal Institute of Technology
- Andreas Unsoeld - Head of Cell Culture Media, Boehringer Ingelheim
Spotlight Presentation – Calling all Technology Thought Leaders!
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Monitoring the effects of critical process parameters on CQAs requires fast and reliable methods. Here we present CQA data monitoring the impact of a temperature shift on the cNISTCHO mAb using an innovative, fast and robust IP-RP-HPLC-MS based characterization approach. With an optimized dilute-and-shoot method we determined CQAs on an intact mAb level.
- Thomas Berger, MSc - PhD student, Department of Biosciences and Medical Biology, University of Salzburg
Optimizing and innovating workflows in cell line development is essential for enhancing efficiency, productivity, and quality in the biopharmaceutical industry. By streamlining processes, leveraging advanced technologies, and fostering collaboration, organizations can achieve faster development timelines, reduce costs, and produce high-quality therapeutics. Embracing these advancements will drive the future of cell line development and contribute to the successful delivery of innovative therapies.
- Rolf Kohler - Group Lead, Novartis Pharma
- Harnessing continuous downstream processing for biopharmaceutical production.
- The implementation of Process Analytical Technologies (PAT) in continuous downstream operations.
- Technologies and applications for continuous bioprocessing.
- What does this hold for the future of continuous processing?
Cross-team collaboration: integrate sustainability principles across the downstream spectrum
Industry collaboration to drive sustainability across the biopharma industry
The Regulatory Landscape: Navigating EMA and MHRA requirements and view for Sustainable Solutions
Minimizing biological load in waste streams: strategies and best practices
The Role of Innovation: developing new technologies and approaches for a greener future
The importance of facility design for achieving sustainable manufacturing goals
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
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In response to increasing global demand for a life-saving monoclonal antibody product, MSD introduced a new drug substance manufacturing site in 2022. The existing drug substance sites do not have enough capacity to meet the long-term anticipated demand. The rapid approval and implementation of this expansion of manufacturing capacity was critical to patient supply, as the number of approved oncology indications raised from 2 in 2015 to over 40 in 2022, covering all major cancer types.
This presentation will provide a MSD post approval change example showcasing the effective and successful application of reliance across European, Middle East and African EMEA markets. It will show how the process worked, challenges faced, mitigations and benefits realized in terms of supporting and accelerating supply of products to patients.
Similar biological drug substance site variations face numerous challenges in terms of implementation strategy due to global regulatory divergence, with different data and submission requirements and lengthy approval timelines. To accelerate patient access, innovative mitigation strategies were implemented for this change including leveraging agile regulatory CMC strategies with a specific focus on ICH Q12 tool, Post-Approval Change Management Protocol (PACMPs), bundled submissions with harmonized Module 1 requirements, and optimal use of available reliance pathways. The project achieved accelerated submissions and approvals through alignment of submission requirements, streamlining of submission plans and utilization of PACMPs where applicable. This regulatory strategy accelerated submissions for 65 countries in the EMEA region. Approvals were received in 60% of countries in less than 2 months, including 18 approvals without any question, up to 2 years ahead of schedule. This includes the first PACMP submitted and approved in Kazakhstan. The agile Regulatory CMC strategies including the implementation of PACMPs and use of available reliance pathways, played a crucial role in accelerating the implementation of this new source of supply and ensuring efficient post-approval change management.
This case study will provide detailed description on how reliance was leveraged and confirms the significant benefits that international convergence in requirements and effective reliance pathways offer to industry, regulators and patients by accelerating access to safe and effective products, providing streamlined management of submissions and resources, together with predictable, timely approvals.
- Fast development of processes in compliance with regulatory needs
- Reducing costs and timelines without compromising on quality
- Matching capacity with demand
- Jayanth Sridhar - CEO and Global Head of Biologics, Dr Reddy’s Laboratories Ltd.
Spotlight Presentation – Calling all Technology Thought Leaders!
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Optimizing production efficiency, scalability, and product quality is crucial for the successful manufacturing of viral vectors used in gene therapies and vaccines.
bespark*bio focuses on developing streamlined, high-performance processes that ensure consistent and reliable viral vector outputs. Our approach integrates cutting-edge bioprocessing expertise with advanced digitalization tools, including machine learning, to enhance process optimization. By utilizing modular framework technologies and pre-defined building blocks, we accelerate experimentation, reduce reliance on trial-and-error, and enhance overall precision. This methodology significantly speeds up process development while minimizing the risks of experimental setbacks.
- Dieter Palmberger - CTO, bespark*bio
- Guido Moll - Assistant Coordinator EU-H2020 ATMP & GMP Projects, Charité, Universitätsmedizin Berlin, Germany
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
By leveraging cell therapy processing technology, we can address the challenge of scaling up cell production for mass consumption. Utilization of a proprietary, cost-effective micro-carrier formulation that surpasses conventional, pharma-focused options in both price and food industry compatibility. This innovation unlocks unprecedented scalability and efficiency for both cultivated meat and cell therapy applications.