Responses to FDA Gene Therapy Letter : Adenovirus Vector Titer Measurements and RCA Levels

7/27/01


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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

Author: STEVE BAUER