Table of Contents
Responses to FDA Gene Therapy Letter : Adenovirus Vector Titer Measurements and RCA Levels
PPT Slide
PPT Slide
Purpose
PPT Slide
Characterization of Particles in Adenovirus Vector Products
Impact of VP, IU, RCA: Safety, Efficacy, Production
Development of Adenovirus Reference Material
What Will Be Accomplished by Reference Material Development?
Reference Material Development
Adenovirus Reference Material Production Scheme
Purpose
Changes in Recommendations
Change in Recommendation on Particle to IU ratio
Change in Recommendation on RCA Limit
Purpose
Application of RCA Recommendation
ALARA vs Risk Based
Wild-type Adenovirus in Bone Marrow Transplantation
Lessons Learned from Patients with Primary or other Secondary Immunodeficiencies
Topics for Discussion
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Author: STEVE BAUER
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