Discussion to Focus on Early Risk Detection, Regulatory Compliance, and Advancing Safer, More Effective Therapies During Cell Line Development
KAISERAUGST, Switzerland, May 6, 2025 -- Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, today announced that Daniel Galbraith, PhD, Chief Scientific Officer, will be speaking at the American Society of Cell and Gene Therapy (ASGCT) 28th Annual Meeting, taking place May 13-17, 2025, in New Orleans, LA. Bringing together thousands of scientists, clinicians, industry leaders, and patient advocates from around the world, the meeting showcases cutting-edge research, clinical breakthroughs, and emerging technologies in the field of cell and gene therapy.
The session, titled, "Targeted Locus Amplification (TLA): Meeting Regulatory Demands for Safer Lentiviral Vectors," will underscore the importance of early and precise genomic analysis in ensuring the safety of lentiviral vector (LVV)-based gene therapies. As regulatory agencies increase their scrutiny around risks such as insertional mutagenesis, this presentation will highlight how TLA supports Investigational New Drug (IND) applications by providing superior sensitivity and specificity in integration site mapping and vector characterization.
"As gene and cell therapies progress toward broader clinical use, the pressure to ensure vector safety continues to grow. Regulatory agencies are asking deeper questions, and we need to be ready with better answers," said Dr. Galbraith. "TLA helps us pinpoint integration risks early, enabling data-driven decisions that not only meet regulatory standards but also ensure safer, more effective therapies. I look forward to engaging with colleagues at ASGCT to explore how we can accelerate the development of these therapies, with precision and patient safety at the forefront."
Session information:
- Presentation Session: Moving Lentiviral Vectors Through the Investigational New Drug (IND) Process
- Presentation Topic: Lentivirus Integration and Mechanisms; Targeted Locus Amplification Platform
- Presentation Date/Time: Tuesday, May 13, 2025, 9:55 – 10:25 AM CT
- Location: Room 265-268
By combining state-of-the-art technologies with deep scientific expertise, Solvias continues to innovate in the development of safer, more effective cell and gene therapies. The new Center of Excellence in Cell and Gene Therapy, which opened earlier this year in Research Triangle Park, NC, further strengthens the company's commitment to advancing transformative therapies for areas such as cancer and rare diseases, bringing critical analytical services closer to U.S. biotech companies and accelerating their path to clinical success.
About Solvias
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Its expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards. For more information, visit solvias.com.
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