Early Registration Deadline:
- 00Days
- 00Hrs
- 00Mins
- 00Secs
Day One (13th May 2025) - CET/CEST (Cent Europe Summer, GMT+2)
- Bjarne Poulson, PhD - Cell Culture Specialist, Novo Nordisk
- David Garcia Munzer - Director Scientific Office DSD, 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.
Contact us today to learn more: Partners@informaconnectls.com
Can we create a platform approach to cell engineering?
- Shan-Hua Chung - Senior Scientist, People Lead Cell Technologies, Roche
- David Öling - Director, Molecular Biology and Recombinant Protein Production, AstraZeneca
How can we overcome current challenges of Protein A:
- E.g. Cost, Capacity, Specificity
Emerging chromatography approaches: Mixed-mode, novel Affinity Ligands, membrane chromatography etc.
Improving future outlook for efficiency, cost-effectiveness, and sustainability in antibody purification
- Electrochemically-controlled purification of antibodies
- Molecularly-imprinted polymers for protein purification
- Magnetic separation processes
- Sebastian Schwaminger - Associate Professor, Medical University of Graz
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
In modern biopharmaceutical manufacturing, data analytics and machine learning (DA/ML) play a vital role in improving process efficiency and ensuring high product quality. This presentation will explore methodologies for applying DA/ML tools to analyze comprehensive biomanufacturing datasets, with a focus on monoclonal antibody production. By strategically selecting predictive models tailored to specific data, these methods improve process optimization and accuracy. The integration of batch and time-series data further enhances model precision by capturing batch-to-batch correlations, demonstrating the broad applicability of these approaches across biomanufacturing processes
- Moo Sun Hong - Assistant Professor, Seoul National University
While AI's transformative power is well recognized across industries, its potential in pharmaceutical bioprocessing remains underexploited, largely due to limited data availability. In 2019, Raissi et al. introduced Physics-Informed Neural Networks (PINNs), creating a new paradigm by integrating deep learning with first-principles physical laws. This innovative approach enables the effective use of AI even in data-scarce environments, presenting a groundbreaking opportunity to revolutionize biopharmaceutical processes by reducing costs and accelerating the time-to-market for new therapies. This presentation will showcase one of the first applications of physics-informed AI in bioprocessing, featuring practical case studies developed in collaboration with industrial partners.
- Ignasi Bofarull-Manzano - Industrial PhD Candidate, CMC Data Scientist and Consultant, RWTH Aachen University
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
The first translation of a research process into GMP is always critical. This presentation covers the case of MUVON Therapeutics, how they managed this first translation, touches on hurdles and presents first results of their clinical trials.
- Jenny Ann Prange - Head of Production, CTO and Co-founder, MUVON Therapeutics AG
Early-stage process development & optimization is crucial
Case studies: Successful optimization strategies & their impact
QbD & other tools for efficient process development
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
This presentation will explore the role of continuous monitoring and Process Analytical Technology (PAT) in upstream bioprocessing, with a focus on the benefits of real-time production insights. We will discuss how live monitoring in bioreactors generates vast amounts of data and the importance of effective computational tools and statistical modeling to analyze this information. Key topics include the critical need for timely issue detection to prevent delays and ensure consistent process control, as well as strategies for optimizing production based on real-time data analysis.
- Imke Vohs - Associate Scientist USP, MSD
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
Piggybac, Leap-In, Sleeping Beauty – case studies on how these compare to random integration and have advantages been achieved?
Comparison of targeted integration (TI) and PiggyBac integration
Impact of copy number and integration sites on productivity and stability
- Moritz Schmidt - Head of Laboratory Molecular Biology, Boehringer Ingelheim
When generating CHO based production clones, a significant amount of time is spent selecting clones and creating an optimal bioprocess. Our research indicates that these steps can be entirely skipped simply by employing a recombinase-based targeted gene integration strategy. The clones generated this way, all behave similarly in bioprocess suggesting that a one-time pre-optimized bioprocess is all you need.
- Lasse Ebdrup Pedersen - Associate Professor, The Technical University of Denmark
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
Academic and Industry perspectives
Deep-dive into latest trends and innovations within the chromatography 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
- Stefano Menegatti - Associate Professor, North Carolina State University
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
Biopharma industry needs a workforce proficient in both traditional and advanced technologies.
Significant skills gap exists in areas like data science, automation, cybersecurity, and sensor technologies.
Targeted training and upskilling programs are needed to address the gap.
Collaboration between education and industry is essential for future workforce preparedness.
- Jason Beckwith - Research Group Lead, University of Dundee
Join us around the fire for a deep dive with speaker Jason Beckwith.
- Jason Beckwith - Research Group Lead, University of Dundee
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
Unique challenges of scaling up CGT manufacturing and how real time analytics can be used to aid in scale up
Implementing PAT (Process Analytical Technology) and other real-time monitoring tools
- Using data to identify and address process deviations proactively
- Building a robust data infrastructure for ATMP manufacturing
Importance of tech transfer:
- How to approach this
- Best practices
How automation can be implemented for increased throughput, fewer errors, better control
Examples of successful automation in CGT manufacturing
- Case study: what was used, done, and the results
Challenges & considerations
- Approaching questions surrounding equipment & software choice
- Validating new tech into existing processes
- Lior Raviv - Chief Technology Officer, Pluri Biotech Ltd
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
Small-scale process transfer, pilot scale, timelines and costs are critical aspects of biopharmaceutical development. Such transitions often encounter significant challenges, including maintaining product quality while ensuring process consistency. This talk will explore aspects of small-scale transfer and scale-up to pilot challenges in the frame of biosimilars upstream process development. By addressing these challenges, we aim at streamlining the transfer and the scale-up journey, reducing development timelines, and enhancing the overall efficiency of our transfer and scale-up activities.
- Simon Fradin - Senior Manager / Lab Head Upstream Process Development, Biopharmaceutical Product Development, Fresenius Kabi
This session will interview a member from a sending and receiving site and identify the pain points from both sides that come with transferring technology and processes. How things have changed, and how they will change in an era of digital transformation and an ever increasing need to simplify.
Data lakes, interrogation and digitalization
Leveraging historical data
Skinny process validation
- Jose Miguel Escandell Planells - Principal Scientist, iBET - Instituto de Biologia Experimental e Tecnológica
- Benedikt Greck - Doctoral Student, Platformization of Complex Molecules, Amgen
- Patrick Garidel - Global Development CMC Biologicals, Boehringer Ingelheim
- Neil Watson - Principal Scientist, UCB
A bioreactor is a complex system goverened by physical, chemical, and biochemical phenomena, fluid dynamics, and process control. A comprehensive mathematical model should include mass balances for the headspace, bubbles, and culture medium, gassing and mixing cascades, feeding, sampling, as well as control loops for pH and dissolved oxygen control. Correlations for mass transfer coefficients and specific power inputs are needed for each bioreactor considered, and a fitting procedure can be used for obtaining the kinetic expressions for the basic cell metabolites.
The developed digital twins can then be used to simulate operation under various conditions, and can support scale-up, transfer, experiment planning, small-scale model development, process characterization, and for troubleshooting.
- Andrej Pohar - Senior Expert Science & Technology, Novartis
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
- Lior Shaltiel - CEO, NurExone Biologic
Overview of ATMP regulatory requirements & challenges
Benefits of early & proactive engagement with regulators
Best practices for effective communication & collaboration
- How can the industry and regulatory bodies "grow up" together, learning and evolving in tandem.
Understanding regional differences:
- EMA vs MHRA vs FDA
- Difference in identity testing requirements between regions
Importance of understanding and complying with updated regulations (e.g. Annex 1)
- Tiffany Rau, PhD - Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
The bioprocessing industry is in constant flux, with new regulations, groundbreaking innovations, and evolving compliance standards. Join us for expert insights on emerging trends, regulatory hurdles, and best practices for maintaining compliance while driving innovation in the world of bioprocessing.