Lauren Gilfillan

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About

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MSc in Industrial Biotechnology
University of Strathclyde
Antibody drug conjugates, ELISA, Potency bioassays, Assay qualification and validation
Senior Study Manager

Lauren brings nearly a decade of experience in bioassay development, potency strategy and analytical support for biologics, gained across both CDMO and CRO environments. She holds an MSc in Industrial Biotechnology from the University of Strathclyde and has built extensive expertise in designing assays that meet the evolving needs of early discovery through IND-enabling development and commercial validation. 

 

Her background centres on the development, optimisation, and phase-appropriate qualification and validation of ligand-binding and cell-based potency assays, with a strong focus on generating robust, reproducible methods aligned with regulatory expectations for IND submissions. Lauren has supported a broad range of therapeutic modalities and applies a strong platform-based approach to assay design enabling efficient translation of early concepts into scalable, fit-for-purpose testing strategies. 

 

Within immunology, Lauren applied her assay development expertise to primary immune cell assays to interrogate mechanism of action for early-stage therapeutics targeted in immune-oncology and allergic diseases. She has driven the development of functional readouts, including, Fc mediated effector function, cytokine profiling, immune cell activation, and pathway-specific responses to characterise biological activity, establish potency, and de-risk candidate progression. Her work provides critical mechanistic insight and data packages that inform candidate selection and regulatory strategy. 

 

Lauren partners closely with customers to deliver scientifically rigorous, regulatory-ready bioassay solutions, combining technical depth with a collaborative, solutions-focused approach to advance programmes from discovery through IND and into the clinic.  

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