Since 2017, Amy has built extensive experience within CRO environments, supported by a strong background in GMP-regulated laboratories. Joining RoukenBio in 2018, she has proven expertise across all phases of bioassay development - from cell culture and assay execution to data interpretation, with a secondment to Innovation contributing to the development of the IndEx-2 cell platform system.
This comprehensive, hands-on experience enables Amy to have a meticulous and informed approach to study management, with a strong attention to detail at every stage of the bioassay lifecycle.
Resources
Research Posters
30 June 2026
|4 min read
This poster illustrates how complex primary cell-based assays contribute to biosimilar comparability by addressing key mechanisms of action and fulfilling roles central to regulatory expectations integrating biological activity assessment, indication extrapolation and the linkage of analytical data with clinical relevance.
Research Posters
15 May 2026
|5 min read
Proving biosimilar comparability requires more than assumed Fc silencing. Even widely used ‘silent’ mutations can retain residual activity, making advanced binding and functional assays essential to accurately characterise Fc properties and meet regulatory expectations.
