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Day Three (15th May 2025) - CET/CEST (Cent Europe Summer, GMT+2)
We develop cultivated seafood as sustainable protein source from fish cell culture. The scale-up of fish cell biomass production requires cultivation in suspension. Fast proliferation, high viability, and scalable process conditions are desirable. Suspension adaptation and continuous optimization allow us to produce fish cell biomass as spheroids in suspension. Suspension cultivation of a rainbow trout cell line was performed in shake flasks, lab- and pilot-scale bioreactors up to 500L stirred tank bioreactors, in batch, fed-batch and perfusion mode.
- Karen Wohlers - Interim Team Lead Bioprocessing Development, Bluu Seafood
- A Representative - |, Novartis
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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A remaining challenge in the development of therapeutic monoclonal antibodies for patient self-administration is elevated viscosity risk at high concentrations and emerging new antibody-based formats are growing in interest for therapeutic applications. This presentation will cover some of the challenges in the developability profile of monoclonal antibodies and novel formats, using case study-based examples using orthogonal analytics.
- Zahra Rattray - Senior Lecturer, Strathclyde Institute of Pharmacy and Biomedical Sciences
- Stephane Busso - CLD Scientist, Biopharmaceutical Product Development, Fresenius Kabi
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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- Julia Müller - PhD Student, University of Applied Sciences and Arts Northwestern Switzerland
Antibody Drug Conjugates (ADCs) are biotherapeutic medicines consisting of a drug (chemotherapeutic agent), a (non-)cleavable linker, and a monoclonal antibody. The current progress on the development of the reduction/conjugation and purification processes for the next-generation ADCs will be explained using single-use materials and lean processes. Moreover, characterisation of the ADCs with physicochemical/biochemical studies and the challenges to handle cytotoxic payloads will be presented.
- Michel Eppink - Senior Director - Downstream Processing, Byondis B.V.
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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Forecasting and proactively addressing potential bottlenecks through real-time data analysis
Ensuring uninterrupted supply of raw materials
Is there still a knock-on effect from COVID?
- Vighnesh Balan - Global Supply Chain Business Excellence Lead, Takeda
The Make-or-Buy question – what should you outsource and what to do in-house?
The benefits and challenges of outsourcing biologics development and manufacturing
How to best select and manage your CDMO
Good contract making, and how to protect your IP
Establishing and managing a productive partnership
- Ulrich Rümenapp - Senior Biotech Program Lead, Bayer AG
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
Successful CGT supply chain & logistics from product development to patient receiving treatment
Collaboration is key:
- Working with manufacturers, logistics, healthcare providers
Cold chain & real-time tracking for product integrity & safety
Sustainable and ethical cell sourcing for allogeneic: building trust and transparency in the cell supply chain
- The whole journey
- Omkar Kawalekar - Co-Founder, BlueWhale
The rapid advancement of gene therapy has driven a surge in demand for clinical-grade viral vectors. This presentation aims to provide a comprehensive analysis of the current and projected demand for viral vectors, focusing on the capacity of Contract Development and Manufacturing Organizations (CDMOs) to meet this growing need. By employing advanced modeling techniques, we will investigate the potential bottlenecks in the supply chain and identify areas where strategic investments can be made to ensure a sustainable and scalable supply of viral vectors for the gene therapy industry.
- Andrew Harmon, MBA - Senior Consultant, Strategic Consulting, Latham BioPharm Group
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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Bavarian Nordic (BN) is a leader in travel vaccines and a trusted partner in public health. BN developed a novel Virus-Like Particle-based Chikungunya (CHIKV VLP) vaccine, which has received accelerated assessment from FDA and EMA, with approval expected in 2025. Challenges and key aspects of the Process Performance Qualification (PPQ) campaign for CHIKV VLP will be presented. The project's success reflects the collaboration of BN's global teams and BN's stakeholders
- Lenny Zaffaroni, PhD - Senior Scientist, Bavarian Nordic
- Explore strategies to improve yield and titer for CoG reduction
- Learn about the connection between CoG reduction and sustainability
- Gain practical examples and insights from industry case studies
- Deborah Hol-Schop - Principal Scientist Upstream Processes, Byondis
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
- Niall Barron - Principal Investigator, NIBRT
- Lekan Daramola - Consultant, Freelance
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
- Sofia Carvalho - Senior Scientist, iBET
The applications of computational tools such as Artificial Intelligence and Predictive Modelling within the purification process
Bridging the gap between academia and industry in AI and Predictive Modelling adoption
Chromatography optimization
Reduction of manual tests to lower costs
Accelerating time to market with AI tools
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
How CDMOs have evolved in the last 5 years and what to expect in the coming years
Geopolitical uncertainty and its impact on outsourced manufacturing
Collaboration to understand the changing needs of pharma and biotech
- Ulrich Rümenapp - Senior Biotech Program Lead, Bayer AG
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
Key drivers of high CGT costs
Strategies: Process optimization, automation, new tech
Collaboration across the CGT ecosystem is essential
- Tiffany Rau, PhD - Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
Overview of challenge landscape in Europe and beyond:
- Pricing, reimbursement, un-unified healthcare providers, HTA
- High cost of therapies, impacts on pricing and reimbursement
- Limited real-world evidence data
Global vs. regional considerations: Balancing harmonization with regional needs, adapting strategies, ethical considerations
Innovative strategies:
- Value-based pricing and innovative payment models
- Early & proactive engagement with payers and HTA bodies
Importance of patient advocacy and education
Navigating the complexities of the European regulatory and HTA environment
- Balancing the need for global harmonization with regional specificities
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
- Understand the benchmarks in fed-batch, intensified, and perfusion processes.
- Learn about the key hurdles in choosing cell culture methods.
- Discover strategies for media development to boost cell culture and product quality.
- Explore the impact of molecule-dependent processes on media requirements.
- Verena Fischer - Lab Head Early Stage Upstream Development, Boehringer Ingelheim
This panel discussion will bring together experts from both upstream and downstream teams to discuss the challenges and opportunities in integrating these two critical stages of biomanufacturing. The conversation will focus on the harvest step as a key point of integration, exploring how upstream activities can influence downstream purification processes. Panellists will share insights on their limitations, expectations, and strategies for improving collaboration to reduce costs, optimize timelines, and enhance overall production efficiency.
Improving efficiency, scalability, and consistency in cell therapy manufacturing
Impact of automated systems on improving cell therapy production timelines and outcomes
- Thomas Jostock, PhD - Associate Director, Novartis
- Iris Bodenmann - Director, Cell Line Development, NewBiologix
- Downstream process is a key bottleneck in the manufacturing of recombinant adeno-associated viral vectors (rAAV) for gene therapy and learnings from other biologics platforms can be challenging to adapt to rAAV modality.
- Current thinking on rAAV downstream process and challenges faced during purification development.
- Viral safety considerations of rAAV downstream process and early-phase viral clearance study.
- Yu-Tsan (Richard) Liu - Sr. Scientist, UCB Pharma
- Rundown from the week’s content and learnings:
- Regulatory Updates: navigating the latest EMA and MHRA Guidelines
- Addressing the Evolving Landscape of CDMOs and Pharma Companies
- CDMO Perspectives: Insights on Outsourcing Downstream Processing
- Best Practices: Sharing Knowledge and Expertise for Optimized Processes
- The Future of Downstream Processing: Trends, Innovations, and Challenges
- Cost considerations In downstream processing: optimizing for efficiency and profitability.
Combatting the unique challenges of manufacturing ATMPs
Incorporating PAT for automated production
Ensuring consistency and quality of the end-product
- Ben Weil - Director of Manufacturing, INmune Bio
Overcoming logistical and regulatory challenges
Cost reduction without compromising on quality
Opening conversations with regulators and healthcare hubs to capitalise on this expertise
- Regional differences (nationalised vs. private healthcare systems)
Potential for point-of-care manufacturing to enable truly personalised cell therapies
- Omkar Kawalekar - Co-Founder, BlueWhale
- Ben Weil - Director of Manufacturing, INmune Bio
Combatting the unique challenges of manufacturing ATMPs
Incorporating PAT for automated production
Ensuring consistency and quality of the end-product
- Ben Weil - Director of Manufacturing, INmune Bio
Overcoming logistical and regulatory challenges
Cost reduction without compromising on quality
Opening conversations with regulators and healthcare hubs to capitalise on this expertise
- Regional differences (nationalised vs. private healthcare systems)
Potential for point-of-care manufacturing to enable truly personalised cell therapies
- Omkar Kawalekar - Co-Founder, BlueWhale
- Ben Weil - Director of Manufacturing, INmune Bio