Analytical Development of Cell and Gene Therapies
Sunday, March 2, 2025 2:30 PM to 4:40 PM · 2 hr. 10 min. (America/New_York)
Room 206A
Symposium
Pharmaceutical & Biologics
Information
Cell and gene therapy (CGT) represent the forefront of medical innovation, offering unprecedented potential to treat, cure, and even prevent a wide array of diseases that were once considered untreatable. We saw a surge on the number of CGT approvals from health authorities in the past several years. mRNA based vaccine help people to fight the global pandemic from COVID-19. The first CRIPSR based therapy was approved in 2024 by FDA.
The rapid advancements in CGT field have already led to groundbreaking successes in treating patients. However, on the Chemistry, Manufacturing and Control (CMC) side, CGT present significant analytical challenges due to the novel drug modalities, diversity of species, and the complex manufacturing and delivery method. There are emerging interest in the analytical chemistry field in discovery, characterization, quality control and bioanalysis of the CGT. This session will focus on solutions to solve these analytical problems coming from academic, fundamental, and applied research laboratories.
This session dedicated to the analytical development of cell and gene therapy will not only showcase the latest scientific breakthroughs in solving the analytical challenge of the new modalities but also inspire discussions on the manufacturing, control and regulatory bringing these cutting-edge therapies from the lab to the clinic. This is an exciting opportunity for the audience to engage with the industrial leads of cell and gene therapy and to explore its future impact.
The rapid advancements in CGT field have already led to groundbreaking successes in treating patients. However, on the Chemistry, Manufacturing and Control (CMC) side, CGT present significant analytical challenges due to the novel drug modalities, diversity of species, and the complex manufacturing and delivery method. There are emerging interest in the analytical chemistry field in discovery, characterization, quality control and bioanalysis of the CGT. This session will focus on solutions to solve these analytical problems coming from academic, fundamental, and applied research laboratories.
This session dedicated to the analytical development of cell and gene therapy will not only showcase the latest scientific breakthroughs in solving the analytical challenge of the new modalities but also inspire discussions on the manufacturing, control and regulatory bringing these cutting-edge therapies from the lab to the clinic. This is an exciting opportunity for the audience to engage with the industrial leads of cell and gene therapy and to explore its future impact.
Day of Week
Sunday
Session or Presentation
Session
Session Number
SY-07-00
Application
Biomedical
Methodology
Liquid Chromatography/LCMS
Primary Focus
Application
Morning or Afternoon
Afternoon
Register
Register Now
Speakers
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Bingchuan Wei
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Understanding the Impact of In Vitro Transcribed mRNA Impurities on Cellular Responses
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Room 206A
Julien Camperi · Genentech
A Multi-attribute Method Supporting the Process Development for Non-viral Gene Therapy
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Wei-Chiang Chen · Sanofi
Physiochemical and Biophysical Characterization of Base Editing Drug Products
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Bo Yan · Beam Therapeutics
Unveiling the Structural Complexity of Guide RNA, A Critical Reagent Used in CRISPR Gene Therapy
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Bingchuan Wei · Genentech