Analytical Challenges for Gene Therapy

One of the biggest challenges for AAV gene therapy products is establishing an appropriate analytical strategy to support product manufacture, release, stability, comparability and characterization at different stages of development. This presentation will highlight some of the existing analytical challenges and provide guidance on the development of an appropriate strategy to help overcome these.
Presented by Clare Blue, Director of Analytical Development at Biogen
 

 
Clare Blue holds a degree and PhD in Molecular Microbiology from the University of Glasgow, Scotland, UK. She has industry experience ranging from viral / vector manufacturing, biosafety testing, analytical development, QC and process development. Clare has been involved in AAV gene therapy for 6 years, initially at Nightstar Therapeutics where she held senior roles overseeing the manufacturing and analytical strategy of phase II/III AAV products for treating retinal diseases.  In her current role as Director of Analytical Development, Biogen, she leads the analytical strategy for ophthalmology gene therapy products.
And followed by Dr Saba Hussein, Applications Manager and Senior Scientist at Vironova
 

Dr Saba Hussein Gore the is Applications Manager and Senior Scientist at Vironova, where she leads the global team of Applications Specialists, based in Stockholm, Sweden. She has a BSc in Virology from the University of Warwick, UK, an MSc in Virology from Imperial College London, UK, and a PhD in the structure and function of membrane proteins from the Laboratory of Molecular Biology (LMB) at the University of Cambridge, UK. She has previously worked as a technician and project manager at Imperial College London in a Gates Grand Challenges in Global Health HIV vaccine consortium, as a postdoctoral fellow in structural and molecular biology of membrane proteins at NYU, USA, and at Stockholm University, Sweden, and as a protein scientist at Sobi, Sweden. She has several publications in leading journals and has presented at leading conferences and engaged with biopharmaceutical clients in Asia, Europe and the USA.
Sponsored by Vironova
Vironova is a Swedish biotechnology company providing comprehensive hardware, software, and services for the analysis of nanoparticles. Vironova revolutionizes access to transmission electron microscopy–based image analysis in biopharmaceutical development. Our solution enables automated analyses for faster and better-informed decisions to secure robust bioprocessing and final product quality.