Session Details

Session Details

03:45 PM - 05:30 PM - Room 314-317

Sixuan Li - Johns Hopkins University

Co-Chair

03:45 PM - 05:30 PM - Room 314-317

Angela Johnson - MSE, PMP, RAC - Northeastern University; Cytiva

Co-Chair

03:45 PM - 04:02 PM - Room 314-317

Patricia Kiesler - PhD - National Institute of Standards and Technology

123: FDA and NIST Collaboration to Evaluate Assays and Control Materials for Characterizing Animal Biotechnology Products Generated by Genome Editing

04:02 PM - 04:19 PM - Room 314-317

Xiang Liu - Johns Hopkins University

124: Purification Process Optimization of mRNA Lipid Nanoparticles via Microfluidic Platform to Improve Payload Distribution and Transfection

04:19 PM - 04:36 PM - Room 314-317

Hans Huber - PhD - Biomay

125: Recombinant Nuclease Cas9 for Therapeutic Genome-Editing - The GMP Manufacturer´s Point of View

04:36 PM - 04:53 PM - Room 314-317

Nandu Deorkar - Avantor

126: Addressing the Impact of RM Critical Quality Attributes and Variability on Complex Biologic Manufacturing

04:53 PM - 05:10 PM - Room 314-317

Daniel Kota - Houston Methodist Research Institute

127: Validation of Rapid Microbial Testing in an Academic GMP Cell Therapy Facility

05:10 PM - 05:27 PM - Room 314-317

Limin Wang - Ph.D - Cytiva Global Regulatory Strategy

128: Systematic Analysis of Primary Field Data from Biologics Therapy Regulatory Non-Approvals: Why Aren’t We Talking About FDA Rejections?