Day Three (15th May 2025) - CET/CEST (Cent Europe Summer, GMT+2)
- Benedikt Greck - Doctoral Student, Platformization of Complex Molecules, Amgen
- Zahra Rattray - Senior Lecturer, Strathclyde Institute of Pharmacy and Biomedical Sciences
- Stephane Busso - CLD Scientist, Biopharmaceutical Product Development, Fresenius Kabi
- Karen Wohlers - Scientist Bioprocessing Development, Bluu Seafood
A mechanistic modelling approach is presented which can predict cell density, glucose, mAb and amino acid profiles during fed-batch CHO cell cultures at a 250-mL scale. This framework generates 400,000 simulated cell cultures as low-fidelity data, which can support data-driven process optimizations steps and address the challenge of limited available data in biopharmaceutical industry.
- Mohammad Golzarijalal - Postdoctoral research fellow, Computer Information Systems department/ Member, University of Melbourne/ ARC Digital bioprocess Development Hub
- Julia Müller - PhD Student, University of Applied Sciences and Arts Northwestern Switzerland
- Michel Eppink - Senior Director - Downstream Processing, Byondis B.V.
- Transformation and Innovation: Takeda's strategic shift towards innovative therapies and advanced manufacturing modalities.
- Supply Chain Resilience: Ensuring a resilient, agile, and sustainable global supply chain to deliver life-saving therapies.
- Digital Integration: Utilizing IoT for real-time visibility and AI for intelligent decision-making to enhance efficiency and reduce time-to-market.
- Vighnesh Balan - Global Supply Chain Business Excellence Lead, Takeda
- 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
- Tiffany Rau, PhD - Principal Consultant at Biopharma Technical Consulting Ltd & Adjunct Professor Biochemistry and Cell, University College Cork
- Tiffany Rau, PhD - Principal Consultant at Biopharma Technical Consulting Ltd & Adjunct Professor Biochemistry and Cell, University College Cork
- Kat Kozyrytska - Founder, Cell Therapy Manufacturability Program
- Kat Kozyrytska - Founder, Cell Therapy Manufacturability Program
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
- Foundational Challenges:
- What were the initial challenges you faced when building a scalable AAV platform?
- How did you prioritize yield, quality, and cost in your approach?
- Technological Breakthroughs:
- What innovations have made the most significant impact on scalability?
- How do technologies like CRISPR or AI support AAV production?
- Regulatory Insights:
- What role does regulatory compliance play in platform design?
- How do you ensure alignment with global regulatory standards?
- Success Stories:
- Can you share an example where your platform enabled a key drug in the pipeline?
- What lessons were learned during this process?
- Future Vision:
- Where do you see the next big leap in AAV production?
- How can the industry work together to address unmet needs?
- Lekan Daramola - Consultant, LD BioConsulting Limited
- Johan Rockberg - Professor, KTH Royal Institute of Technology
- Tiffany Rau, PhD - Principal Consultant at Biopharma Technical Consulting Ltd & Adjunct Professor Biochemistry and Cell, University College Cork
- Lenny Zaffaroni, PhD - Senior Scientist, Bavarian Nordic
Biopharmaceutical processes are continuously optimized with innovative changes during development and manufacturing at different stages of a bioproduction process. Either to increase yield, shorten timelines, or make the process more efficient, which all will decrease cost of goods and make biopharmaceutical products more affordable. An innovative change can have impact on the cell culture stage, which brings new challenges. A case study will be presented by Byondis.
- Deborah Hol-Schop - Principal Scientist Upstream Processes, Byondis
Advancements in upstream bioprocessing require efficient, scalable, and cost-effective solutions for cell separation and perfusion. As state-of-the-art upstream production is increasingly tied to process intensification, aimed at achieving higher cell densities and product titers, these processes grow more challenging. This presentation highlights a collaborative study between the GEA Group and ProBioGen AG demonstrating how the kytero® Single-Use-Pharma-Separator, can enhance operational flexibility whilst reducing complexity. This high-performance single-use disk-stack centrifuge, helps implement process intensification whilst overcome several challenges related to these process types. The session will cover key insights, including: • Perfusion: High cell density perfusion in CHO-based processes. Comparison of centrifugation and filter-based perfusion technologies. • Cell separation: Unlimited harvest capacity using centrifugation. Overall performance evaluation in combination with and in comparison to depth filtration. • Process Scalability: Integration into both pilot and large-scale upstream workflows. • Operational Simplification and Flexibility: One device for reduced complexity, increased process robustness and maximum efficiency. Attendees will gain a comprehensive understanding of how centrifugation offers a transformative solution for biopharmaceutical manufacturers, paving the way for maximum performance and flexibility in upstream processing.
- Lukas Rositzka - Head of Upstream Processing Production, ProBioGen AG
Deep-dive into latest trends and innovations within the downstream processing world
Emergence of new materials
Utilising new technologies
Overcoming hurdles associated with adopting emerging tech/materials
Gaining regulatory acceptance after changes
Impact on the future of downstream processing
- Marija Brgles - Principal Scientist, Therapeutic Virus Development, Boehringer Ingelheim
- Florian Mayerthaler - Head DSP non-GMP Pilot Plant, Sanofi
- Exploring the evolving world of external collaborations, from CDMOs to tech providers..
- Geopolitical uncertainty and its impact on outsourcing.
- Synergistic collaboration of internal and external partnerships to meet biopharma's evolving needs.
- Maximize innovation by effectively collaborating with technology providers.
- Seamless knowledge sharing and communication between stakeholders.
- Ulrich Rümenapp - Senior Biotech Program Lead, Bayer AG
- Weitao Jia, Ph.D. - Director, Pre-Pivotal Biologics Analytical Development and Product Characterization, Gilead Sciences
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
- Andrew Harmon, MBA - Associate Manager, Management & Strategy Consulting, Sia
- Omkar Kawalekar - Co-Founder, BlueWhale
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
- Benedikt Greck - Doctoral Student, Platformization of Complex Molecules, Amgen
- Niall Barron - Principal Investigator, NIBRT
- Iris Bodenmann - R&D Director, Cell Biology, NewBiologix
- Verena Fischer - Associate Director Upstream Processing at Boehringer Ingelheim, 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.
- Stefano Menegatti - Associate Professor, North Carolina State University
- Claes Nilsson - Senior Cultivation Scientist, Novo Nordisk A/S
- Emilie Aguado - Head of Upstream, MSAT Vitry, Sanofi
- Yu-Tsan (Richard) Liu - Sr. Scientist, UCB Pharma
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.
- Stefano Menegatti - Associate Professor, North Carolina State University
- Claes Nilsson - Senior Cultivation Scientist, Novo Nordisk A/S
- Emilie Aguado - Head of Upstream, MSAT Vitry, Sanofi
- Tiffany Rau, PhD - Principal Consultant at Biopharma Technical Consulting Ltd & Adjunct Professor Biochemistry and Cell, University College Cork
- Ben Weil - Director of Manufacturing, INmune Bio
Defining point-of-care/decentralized manufacturing
The potential of this manufacturing strategy for personalized medicine
Overcoming logistical challenges in point-of-care settings
Ensure quality and meet regulatory standards.
- Regional differences (nationalised vs. private healthcare systems)
The importance of collaboration between stakeholders in point-of-care manufacturing.
Could point-of-care manufacturing enable truly personalised therapies?
- Omkar Kawalekar - Co-Founder, BlueWhale
- Ben Weil - Director of Manufacturing, INmune Bio
- Tiffany Rau, PhD - Principal Consultant at Biopharma Technical Consulting Ltd & Adjunct Professor Biochemistry and Cell, University College Cork
- Ben Weil - Director of Manufacturing, INmune Bio
Defining point-of-care/decentralized manufacturing
The potential of this manufacturing strategy for personalized medicine
Overcoming logistical challenges in point-of-care settings
Ensure quality and meet regulatory standards.
- Regional differences (nationalised vs. private healthcare systems)
The importance of collaboration between stakeholders in point-of-care manufacturing.
Could point-of-care manufacturing enable truly personalised therapies?
- Omkar Kawalekar - Co-Founder, BlueWhale
- Ben Weil - Director of Manufacturing, INmune Bio