Latest news with #Solvias
Associated Press
06-05-2025
- Business
- Associated Press
Solvias to Speak at ASGCT 2025 Highlighting Safer Gene Therapy Development
Discussion to Focus on Early Risk Detection, Regulatory Compliance, and Advancing Safer, More Effective Therapies During Cell Line Development KAISERAUGST, Switzerland, May 6, 2025 /PRNewswire/ -- 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 . Media contact Katy McGirr, Director of Global Marketing [email protected] +1 617 513 8287 View original content to download multimedia: SOURCE Solvias
Yahoo
22-04-2025
- Business
- Yahoo
Solvias to Speak at Festival of Biologics 2025 on Building Robust CMC Assays for Biologic Therapies
Discussion to Cover the Importance of Early-Stage CMC Testing in Enhancing Biologic Predictability, Scaling Up, and Accelerating Time to Market KAISERAUGST, Switzerland, April 22, 2025 /PRNewswire/ -- Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, today announced that Christopher Hepler, Site Head at Solvias' new Center of Excellence for Biologics and Cell & Gene Therapy in Research Triangle Park (RTP), NC, will be speaking at the Festival of Biologics, taking place April 23-24, 2025 in San Diego, CA. The annual Festival of Biologics conference brings together senior biologics professionals across the value chain to showcase their research, collaborate on challenges, forge new connections and ultimately advance the industry to improve patient health. The session, titled, "Building Robust CMC Assays with Developability in Mind," will underscore how robust CMC assays not only improve the predictability of biologics' behavior but also streamline scale-up processes, ensuring a smoother transition from clinical development to commercialization. "Rigorous CMC testing plays a vital role in ensuring the stability, safety, and efficacy of large molecule therapeutics. By integrating early developability assessments and a data-driven approach, we can proactively address potential risks, enhance scalability, and reduce late-stage setback," said Hepler. "I look forward to exploring how these strategies can accelerate the transition from clinical development to market, ultimately delivering innovative treatments to patients faster and more reliably." Session information: Presentation Session: CMC & Developability Presentation Topic: Building Robust CMC Assays with Developability in Mind Presentation Date/Time: Wednesday, April 23, 3:40 – 4:00 PM Location: Theater 5 Solvias launched the opening of its new Center of Excellence for Biologics and Cell and Gene Therapy in RTP in January of this year. The new facility expanded Solvias' global network to six centers of excellence, established a second hub in the U.S. in a growing biotech hub, and reinforced its commitment to advancing transformative therapies for cancer and rare diseases. 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 Media contactKaty McGirr, Director of Global +1 617 513 8287 View original content to download multimedia: SOURCE Solvias Sign in to access your portfolio
Associated Press
27-01-2025
- Business
- Associated Press
Solvias Opens Center of Excellence for Biologics and Cell & Gene Therapy in Research Triangle Park
MORRISVILLE, N.C., Jan. 27, 2025 /PRNewswire/ -- Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced today the opening of its cutting-edge Center of Excellence for Biologics and Cell and Gene Therapy in the heart of Research Triangle Park (RTP), North Carolina. The new facility expands Solvias' global network of centers and reinforces its commitment to advancing transformative therapies for cancer and rare diseases. Spanning 50,000 square feet, the new center is Solvias' flagship North American site for large molecule analytical services designed to accelerate the development and commercialization of innovative biologics. The facility will bring approximately 200 new jobs to the Raleigh-Durham area over the next three years and is being rolled out in two phases: Phase 1: A 20,000-square-foot space for cGMP release testing—featuring cell-based potency and molecular assays—operational immediately. Phase 2: An additional 30,000 square feet expected to open in July 2025, offering expanded capabilities for stability testing and advanced biophysical characterization. Equipped with state-of-the art analytical instrumentation, laboratory automation, and advanced digital management systems, the new center offers comprehensive GMP testing for cell and gene therapies, monoclonal antibodies (mAbs), and other biologics, from preclinical stages to commercial release. 'This Center of Excellence in RTP is a milestone in Solvias' global growth journey,' said Archie Cullen, Chief Executive Officer of Solvias. 'Combining our team's expertise with advanced technology, we aim to set a new benchmark for delivering high-quality, reliable analytical support. It's an honor to partner with our clients in bringing groundbreaking therapies to patients worldwide.' 'We are focused on helping our clients succeed with our analytical expertise. We are hiring the best possible talent to be technical partners for our clients, helping them bring therapies to market faster and more efficiently. With this investment, we are committed to be an integral part of the US biopharma innovation ecosystem,' said Ilya Koltover, Chief Commercial Officer of Solvias. Solvias' new center expands its global footprint to six centers of excellence and marks the company's second site in North America. For more information on Solvias' new Center of Excellence in RTP, visit 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
