Swati Gupta
AbbVie Biotherapeutics, University of Nebraska–Lincoln, IIT@MIT, Rashtrasant Tukadoji Maharaj Nagpur University
About
Dr. Swati Gupta is the Executive Director at AbbVie, in Irvine, California. She is with the company for last 13 years where she leads the Immunology group in Nonclinical and Translational Sciences function. She is serving as an internal consultant and resident expert to provide guidance and advice for risk assessment on modulation of the immune system for therapeutics and devices with a focus on immunogenicity. This group own the responsibilities and provides oversight to ensure compliance with immunology procedures, strategies and processes following expectations from the FDA, EMA and other regulatory agencies. Prior to AbbVie, Dr. Gupta led different positions in leading groups on Clinical Immunogenicity, Bioassay/CMC, Bioanalytical in various pharmaceutical companies like BMS, and Eli Lilly. Dr. Gupta received her Ph.D. degree in Biochemistry/Chemistry from University of Nebraska, Lincoln and did her post-doctoral training at the University of California School of Medicine, Irvine in the Department of Microbiology and Molecular Genetics. Dr. Gupta has several publications in peer-reviewed journals and has in-depth experience in bioanalytical assays in characterizing bio-therapeutics to support mechanism of action, pharmacokinetics, immunogenicity and product release. She is currently actively participating in IQ consortium for TALG- Gene therapy, Cell-Therapy- oligos. She is also participating in AAPS Immunogenicity Risk Assessment community and is contributing to in vitro method harmonization.
Employment
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AbbVie Biotherapeutics
Education
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University of Nebraska–Lincoln Ph.D.
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IIT@MIT M.Tech.
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Rashtrasant Tukadoji Maharaj Nagpur University M.Sc.
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Rashtrasant Tukadoji Maharaj Nagpur University B.Sc.
Projects & Funding
Projects & funding information is unavailable.
Publications (24)
- An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR‐T and TCR‐T Cellular Therapies Development Save
- Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development. Save
- Neutralizing Antibody Formation with OnabotulinumtoxinA (BOTOX®) Treatment from Global Registration Studies across Multiple Indications: A Meta-Analysis. Save
- International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs Save
- Intraocular delivery considerations of ocular biologic products and key preclinical determinations. Save
- Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper. Save
- 2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3– Recommendations on Gene Therap… Save
- 2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosi… Save
- Advancements in Understanding Immunogenicity of Biotherapeutics in the Intraocular Space. Save
- Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics. Save