Sponsored by Millipore Sigma
This webinar will explore the key steps required to transform a promising lateral flow assay prototype into a robust, scalable and routinely manufacturable product. Building on the complementary expertise of Merck Millipore in assay development and Unisensor in industrialization and manufacturing, the session will highlight how an effective technology transfer bridges the gap between R&D and controlled production.
The presentation will cover transfer readiness, including the definition of the target product profile, assay data, material status and quality expectations, before moving into the establishment of a product-specific industrial process window. Particular attention will be given to progressive scale-up through three transfer lots, culminating in a full-scale production batch that can support validation activities, clinical studies or commercial launch once released.
The webinar will also address the main risks that emerge during scale-up, including raw-material variability, process robustness, performance drift and production cost. Finally, it will review the manufacturing controls needed to ensure reliable routine supply, including in-process controls, QC release, packaging, stability studies and batch-to-batch traceability. The objective is to show how coordinated CRO and CDMO expertise can reduce transfer risk, accelerate time to market and secure a reproducible manufacturing pathway for lateral flow products.
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A biochemist by training, she has expertise in protein production, purification, and characterization, as well as antibody-based technologies and lateral flow immunoassays. Before joining Unisensor, she worked in the pharmaceutical industry on allergy immunotherapy products. She holds a Master’s degree and a PhD from the University of Liège, Belgium.
Withmore than 30 years of experience in pharmaceutical and diagnostic manufacturing,Emmanuel has held senior operational leadership positions at GSK, Catalent, Cenexi, and Unisensor. Throughout his career, he has focused on lndustrialzation, manufactizating excellence, engineering, and the successful scale-up of complex production processes.
At Unisensor, Emmanuel leads the company's operations, engineering, industrialization, production, maintenance, and quality control activities. He has built the industrialization capabilities for lateral flow immunoassays (LFIA) and next-generation molecular diagnostic products, enabling efficient technology transfer from R&D to large�scale manufacturing. Under his leadership, Unisensor has expanded its manufacturing capacity to produce more than 15 million diagnostlC tests annually and has launched its Contract Development and Manufacturing Organization (COMO) services to support diagnostic innovators worldwide.
Passionate about translating innovation into industrial reality, Emmanuel works closely with R&D, quality, engineering, and commercial teams to deliver robust, scalable, and cost-effective manufacturing solutions.
In this webinar, Emmanuel will share his experience in outsourcing LFIA manufacturing, highlighting the key success factors for technology transfer, industrialization, quality management, and building effective partnerships with contract manufacturing organizations.
