Senior Research Fellow
AbbVie Inc.
Dr. Swati Gupta is a Senior Research Fellow at AbbVie in Irvine, California, with 14 years of experience at the company. She serves as an internal consultant and expert, offering guidance on risk assessment for immune system modulation in therapeutics, genetic medicine and devices, focusing on immunogenicity. Her group ensures compliance with immunology procedures in line with FDA, EMA, and other regulatory agencies' expectations. Before joining AbbVie, Dr. Gupta held leadership roles in Clinical Immunogenicity, Bioassay/CMC, and Bioanalytical at pharmaceutical companies such as BMS and Eli Lilly. She earned her Ph.D. in Biochemistry/Chemistry from the University of Nebraska, Lincoln, and completed post-doctoral training at the University of California School of Medicine, Irvine. With several peer-reviewed publications, she has extensive experience in bioanalytical assays related to biotherapeutics and genetic medicine. Dr. Gupta contributes to the IQ consortium for TALG-Gene therapy, Cell-Therapy-oligos, and the AAPS Immunogenicity Risk Assessment community.