Navigating the Development of Therapeutic Antibody Drugs from Molecule Design to Quality Control

Mark Lyons, PhD
CEO
Hooke Bio

Speaker Bio:

Dr. Mark Lyons is the co founder and Chief Executive Officer of Hooke Bio Ltd. He earned his DPhil (PhD) in Biochemistry from the University of Oxford. He has 20+ years of experience in microfluidics and diagnostics industries. Prior to founding Hooke Bio, Mark held positions with Radisens Diagnostics, leading microfluidic assay development and Olympus Diagnostics, where he shepherded product development from R&D through to the launch of FDA-regulated diagnostic tests. Since Hooke Bio spun out from the University of Limerick, Dr. Lyons has served as CEO, guiding the company’s growth and technological innovation. Under his leadership, Hooke Bio secured prestigious European Innovation Council (EIC) Accelerator funding in 2023, supporting the development and launch of their flagship “Mera” high-throughput microfluidic platform, engineered to accelerate 3D microtissue drug screening and reduce reliance on animal models

Talk Title:

Dynamic Flow-Based Investigation of T Cell Behaviour in Mera, a Microphysiological System

Hooke Bio leverages its proprietary Mera microphysiological system (MPS) to deliver dynamic fluid flow over physiologically relevant, multicellular 3D tissue models, enabling advanced preclinical evaluation of immunotherapeutic agents. This scalable platform supports the integration of circulating immune cells with complex organotypic constructs, allowing precise investigation of immune cell trafficking, tumour infiltration, and potential off-target effects under flow conditions that mimic human physiology. By recreating immune–tumour interactions in a human-relevant, controlled in vitro environment, Mera facilitates high-throughput screening of novel immunotherapies, characterization of mechanisms of action, and more predictive toxicology. This approach supports improved translational accuracy, contributing to the reduction of late-stage clinical failures and enhancing therapeutic efficacy and safety.

This talk will provide an overview of the Mera platform, outline its core capabilities, and highlight recent studies that illustrate its translational potential in simulating T cell responses and bispecific antibody activity under dynamic flow conditions within the system.

Denise Rohlik, PhD
Manager, Field Applications & Technical Services (EMEA)
Gator Bio

Speaker Bio:

Dr. Denise Rohlik is a structural biologist with expertise in label-free technologies. Based in Basel, Switzerland, she is Gator Bio’s EMEA Field Applications and Technical Services Regional Manager. She earned her Ph.D. in Microbiology and Immunology from the Brody School of Medicine at East Carolina University and has extensive experience in biophysics and protein interaction analysis in drug discovery. Dr. Rohlik specializes in Biolayer Interferometry (BLI) assay development, optimization, and troubleshooting, supporting researchers across the biotherapeutics development pipeline, from early discovery through manufacturing and QC. She also led the establishment of Gator Bio’s European headquarters and demonstration laboratory and collaborates globally to advance innovative BLI applications for biologics, small molecules, and emerging modalities.

Talk Title:

Second-generation biolayer interferometry: a tool for streamlining antibody therapeutic development from discovery to QC

Antibody development is a complex process that spans discovery, engineering, manufacturing, and quality control. Each stage demands analytical tools that are reliable, flexible, and able to keep pace with today’s accelerated timelines. Label-free methods such as Biolayer Interferometry (BLI) are especially valuable because they provide real-time insights into molecular interactions without the need for secondary reagents. Second-generation BLI builds on these strengths with greater sensitivity, higher throughput, and a broad selection of biosensor chemistries designed for antibodies and other complex therapeutic modalities. These advances make BLI a versatile platform that can be applied from early candidate screening and optimization to process monitoring, comparability studies, and QC testing.

By integrating seamlessly across the biotherapeutics pipeline, BLI reduces bottlenecks, complements existing analytical platforms, and accelerates data-driven decision-making. Its ability to deliver actionable information throughout discovery and development ensures greater efficiency and consistency, ultimately supporting the reliable production of high-quality therapeutic products.

Lorenza Ferretti, PhD
Senior Scientist
Memo Therapeutics AG
       

Ruiyuan Zheng, PhD
Marketing Product Manager
ACROBiosystems

Speaker Bio:

Dr. Zheng is a Marketing Product Manager at ACROBiosystems, where she specializes in delivering innovative life science solutions to accelerate biologics development. She earned her PhD in cardiovascular disease research and molecular cell biology from the University of Cologne, followed by postdoctoral research at Heidelberg University, where she worked on organoid-based models for neurodegenerative diseases. In her current role, she combines her scientific expertise with strategic insight, focusing on how qualified raw materials support the compliance of pharmacopoeial standards and enable robust CMC process development. With a strong background in biologics research, drug discovery, and CMC manufacturing across Europe, she is dedicated to driving reagent innovation and shaping strategic solutions that advance drug development.

Talk Title:

Establishing a CMC Process to Streamline Your Antibody Drug Development

Establishing a stringent Chemistry, Manufacturing, and Controls (CMC) process is critical to streamline antibody drug development, from early manufacturing to large-scale production. A robust CMC strategy not only ensures efficiency but also guarantees drug safety and compliance with both universal and local regulatory frameworks, including the U.S., European, and Swiss Pharmacopoeias. Since these guidelines emphasise the quality of raw materials, selecting qualified reagents becomes a cornerstone of successful CMC implementation. This talk will highlight how high-quality raw materials, such as recombinant proteins, antibodies, and analytical kits, including endotoxin and mycoplasma detection kits, contribute to building a reliable and regulation-ready CMC process for your therapeutic antibody development.