Manufacturing processes for gene therapy products are generally low yielding compared to production processes for other biologics. The material requirements to support analytical, comparability, and stability activities at all stages of development could exceed the requirements for clinical dosing. This talk will highlight some of the key material requirements at different stages of development and discuss options for maximizing use of available material.
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 over 7 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 is involved in all aspects of clinical AAV product development. Clare is also an advocate for sustainable development.