#United States #New Orleans #gene therapy #Lentiviral Vector #Solvias

Solvias at ASGCT 2025: A Focus on Safer Gene Therapies

Solvias, a leader in chemistry, manufacturing, and control (CMC) analytics, is set to make waves at the 28th Annual Meeting of the American Society of Cell and Gene Therapy (ASGCT) scheduled from May 13-17, 2025, in New Orleans, LA. At this prestigious gathering, Daniel Galbraith, PhD, the Chief Scientific Officer of Solvias, will deliver a key presentation titled, _"Targeted Locus Amplification (TLA) Meeting Regulatory Demands for Safer Lentiviral Vectors."_

This session aims to address crucial aspects of developing gene therapies that comply with strict regulatory frameworks. With an increasing emphasis on ensuring the safety of lentiviral vector (LVV)-based therapies, Dr. Galbraith's insights will focus on how TLA can enhance early risk detection and ultimately contribute to safer health outcomes.

Meeting the Challenge of Regulatory Compliance

As the landscape of gene and cell therapies evolves, regulatory bodies are scrutinizing integration risks like insertional mutagenesis more rigorously. Dr. Galbraith will elaborate on how TLA can aid in the mapping of integration sites with unmatched sensitivity and specificity, crucial for Investigational New Drug (IND) applications.

_"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. This comment encapsulates the pressing necessity for enhanced analytical techniques and compliance protocols as the industry pushes for broader clinical applications of these therapies.

Presentation Details

• - Session Title: Moving Lentiviral Vectors Through the Investigational New Drug (IND) Process
• - Focus Topics: Lentivirus Integration Mechanisms; Targeted Locus Amplification Platform
• - Date/Time: Tuesday, May 13, 2025, from 9:55 to 10:25 AM CT
• - Location: Room 265-268

By emphasizing precision in analytics, Solvias is at the forefront of fostering safe and effective gene therapy innovations. Moreover, the recent unveiling of its Center of Excellence in Cell and Gene Therapy in Research Triangle Park, NC, demonstrates the firm's dedication to transforming the landscape of therapeutic options for conditions such as cancer and rare diseases. This center not only acts as a boon to U.S. biotech firms but also accelerates the pathway to clinical success, offering critical analytical services.

About Solvias

Founded near Basel, Switzerland, Solvias stands as a global beacon in providing comprehensive CMC analytics for the life sciences sector. Their expert team blends decades of experience with significant regulatory know-how, offering end-to-end solutions encompassing everything from raw material testing to drug product release and API development for small molecules.

With six global Centers of Excellence, all upholding the highest ISO, GMP, GLP, and FDA standards, Solvias remains committed to propelling the development of safer, more effective healthcare solutions. For more information on their offerings, visit solvias.com.

Media Contact

Katy McGirr
Director of Global Marketing
Email: [email protected]
Phone: +1 617 513 8287

In conclusion, the participation of Solvias at ASGCT 2025 is not just a presentation but a commitment to paving the way for safer and more effective gene therapies that promise to reshape patient safety and treatment outcomes across the globe.