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Globe and Mail
a day ago
- Business
- Globe and Mail
Frost & Sullivan: iRegene Therapeutics Honored as "2025 Forbes China Leading Enterprises in Industry Development"
Shanghai, China--(Newsfile Corp. - June 8, 2025) - Recently, The "2025 Frost & Sullivan China Entrepreneurs Annual Conference and Forbes China Pioneer Innovators in Industry Development Selection Gala Evening of Honor," jointly organized by Frost & Sullivan and Forbes China, was successfully held at Regent Shanghai on The Bund. Amid the global trend of industrial innovation, the results of the "2025 Pioneer Innovators in Industry Development" selection jointly initiated by Forbes China and Frost & Sullivan were officially announced. iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development. iRegene is pioneering the future of regenerative medicine with its AI-powered, chemically induced cell therapy platform. By combining cutting-edge technology, a robust R&D ecosystem, and a globally experienced leadership team, iRegene is redefining allogeneic therapies to make them safer, more effective, and broadly accessible. This recognition highlights iRegene's continued leadership in innovation and its commitment to transforming patient care through next-generation regenerative therapies. iRegene Therapeutics Honored as 2025 Forbes China Leading Enterprises in Industry Development Aroop Zutshi, Global Managing Partner and Executive Board Director of Frost & Sullivan, and Junyi Guo, General Manager of Business Operations at Forbes China, jointly presented the 2025 Forbes China Leading Enterprises in Industry Development award. Dr. Jun Wei, Chairman of iRegene Therapeutics, was invited to attend the gala. AI-Driven Chemical-Induced Cell Therapy: Reshaping the Future of Accessible Cell Therapy Since its establishment in 2017, iRegene Therapeutics has remained committed to addressing unmet clinical needs through the development of next-generation cell therapies. With a focus on chemically induced, universal cell therapy products, iRegene aims to deliver transformative treatments for patients with currently incurable diseases. iRegene Therapeutics has a proprietary, AI-based platform for screening chemical compounds to modify specific cellular functions. The platform leverages induced pluripotent stem cells (iPSCs) to enhance treatment potential. By combining compounds to form a chemically induced culture medium, the "AI+Chem" platform can efficiently and precisely reprogram or optimize a cell's fate and function, thereby enhancing the clinical capabilities of cell therapies. With a focus on the chemical induction system, iRegene has developed a comprehensive research and development (R&D) ecosystem and an international patent system that spans the industry. This ecosystem combines the discovery of 'cell fate determinants', the screening of chemical inducers and the validation of cellular function. The system does not use viral vector construction or transgenic methods; the straightforward CMC procedure is cost-efficient. Furthermore, cell transformation and functional optimization are entirely driven by the cells' natural genetic makeup. Transformation is synchronous under chemically enhanced regulation, eliminating the risk of genetic modification. iRegene's pioneering platform has been proven through the positive outcomes of the Phase I clinical trial. In addition, iRegene's executive team has an international perspective, with all members having successful overseas experience in their specialized fields. CEO Dr Wei Jun is a leading expert in regenerative medicine and the induced pluripotent stem cell (iPSC) technology, bringing strategic leadership to the company. Chief Medical Officer Dr Cai Meng has extensive experience taking innovative therapies from discovery through clinical development, while Chief Quality Officer Ren Xiang is a senior regulatory expert who provides solid support from IND approval to NDA clearance in China, the US, and other countries. Executive Vice President Emmanuel Montet, formerly Vice President of the Asia-Pacific region at Ipsen, now leads iRegene's global business development and international strategy. To accelerate global clinical translation and commercialization, iRegene places great emphasis on the philosophy of 'cooperation and mutual benefit'. At the end of 2021, iRegene entered a long-term collaboration with Danaher Corporation to co-develop next-generation platforms for clinical application. Under this partnership, Danaher will play an active role in developing multi-directional platforms for future iRegene Therapeutics projects. This will involve supplying advanced detection instruments and technical resources relating to life sciences research, the development of effective compounds and screening, multi-omics cell mechanism research, and multi-substance screening. Danaher will help iRegene Therapeutics to enhance the efficiency of platform construction and its ability to deliver practical solutions. Danaher will also support iRegene Therapeutics in developing distinctive, innovative drug pipelines and establishing a research and production base. This strategic cooperation has recently been elevated to the iRegene - Danaher Joint Innovation Center, which is the world's first "Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems". The center will focus on integrating artificial intelligence (AI)-driven chemically induced cell therapy R&D with microphysiology systems technology. It is committed to accelerating the clinical translation and application of innovative therapies, and providing patients globally with more precise and effective treatment solutions for diseases. Danaher will fully support iRegene Therapeutics' future planning and development, aiming to jointly advance innovative development in China's life sciences research. iRegene's breakthrough technology platform, strategic advantages and dedicated team have secured continuous support from several leading venture capital firms, with cumulative financing reaching nearly 400 million RMB (55.5 million USD). The company is advancing multiple programs through clinical development, targeting a win-win situation for its products and the capital markets alike, while providing patients around the world with next-generation chemically induced cell therapies that can genuinely reverse disease progression. About iRegene Therapeutics iRegene Therapeutics is a biotechnology company committed to becoming a global leader in universal chemical-induced cell therapy. As one of the first companies to harness AI and + chemical induction for the specific functional modification of cells, iRegene offers a safer, more scalable, and cost-effective alternative to traditional gene or cell therapies. Its pipeline targets diseases with high unmet need, including neurodegenerative disorders such as Parkinson's disease and blindness. Through pioneering science, strategic global partnerships, and a visionary leadership team, iRegene is reshaping the future of regenerative medicine - making advanced therapies accessible to patients worldwide. In August 2023, the NMPA approved the commencement of Phase I clinical trials for iRegene's first product: 'Human Dopaminergic Precursor Cell, NouvNeu001'. This product was developed using the 'AI+ Chem' platform. This made it the world's first chemically induced pluripotent stem cell (iPSC)-derived therapy to enter clinical trials. In June 2024, it was approved by the U.S. FDA for overseas clinical trials. Even more groundbreakingly, in March 2024, iRegene's 'Chemical Induction Platform' became the first system ever to be granted exemption by the FDA. The company's second product, NouvNeu003, which is intended for the treatment of early-onset Parkinson's disease, received NMPA approval in December 2023 and entered Phase I clinical trials. Both NouvNeu001 and NouvNeu003 have now completed Phase I trials. The Phase I results demonstrate good safety, tolerability, and encouraging efficacy in improving motor and non-motor symptoms. The Phase II trial for NouvNeu001 began in April 2025. In parallel, iRegene's first-in-class ophthalmic therapy, was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024.
Associated Press
a day ago
- Business
- Associated Press
Frost & Sullivan: iRegene Therapeutics Honored as '2025 Forbes China Leading Enterprises in Industry Development'
Recently, The '2025 Frost & Sullivan China Entrepreneurs Annual Conference and Forbes China Pioneer Innovators in Industry Development Selection Gala Evening of Honor,' jointly organized by Frost & Sullivan and Forbes China, was successfully held at Regent Shanghai on The Bund. Amid the global trend of industrial innovation, the results of the '2025 Pioneer Innovators in Industry Development' selection jointly initiated by Forbes China and Frost & Sullivan were officially announced. iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development. iRegene is pioneering the future of regenerative medicine with its AI-powered, chemically induced cell therapy platform. By combining cutting-edge technology, a robust R&D ecosystem, and a globally experienced leadership team, iRegene is redefining allogeneic therapies to make them safer, more effective, and broadly accessible. This recognition highlights iRegene's continued leadership in innovation and its commitment to transforming patient care through next-generation regenerative therapies. iRegene Therapeutics Honored as [2025 Forbes China Leading Enterprises in Industry Development] Aroop Zutshi, Global Managing Partner and Executive Board Director of Frost & Sullivan, and Junyi Guo, General Manager of Business Operations at Forbes China, jointly presented the 2025 Forbes China Leading Enterprises in Industry Development award. Dr. Jun Wei, Chairman of iRegene Therapeutics, was invited to attend the gala. AI-Driven Chemical-Induced Cell Therapy: Reshaping the Future of Accessible Cell Therapy Since its establishment in 2017, iRegene Therapeutics has remained committed to addressing unmet clinical needs through the development of next-generation cell therapies. With a focus on chemically induced, universal cell therapy products, iRegene aims to deliver transformative treatments for patients with currently incurable diseases. iRegene Therapeutics has a proprietary, AI-based platform for screening chemical compounds to modify specific cellular functions. The platform leverages induced pluripotent stem cells (iPSCs) to enhance treatment potential. By combining compounds to form a chemically induced culture medium, the 'AI+Chem' platform can efficiently and precisely reprogram or optimize a cell's fate and function, thereby enhancing the clinical capabilities of cell therapies. With a focus on the chemical induction system, iRegene has developed a comprehensive research and development (R&D) ecosystem and an international patent system that spans the industry. This ecosystem combines the discovery of 'cell fate determinants', the screening of chemical inducers and the validation of cellular function. The system does not use viral vector construction or transgenic methods; the straightforward CMC procedure is cost-efficient. Furthermore, cell transformation and functional optimization are entirely driven by the cells' natural genetic makeup. Transformation is synchronous under chemically enhanced regulation, eliminating the risk of genetic modification. iRegene's pioneering platform has been proven through the positive outcomes of the Phase I clinical trial. In addition, iRegene's executive team has an international perspective, with all members having successful overseas experience in their specialized fields. CEO Dr Wei Jun is a leading expert in regenerative medicine and the induced pluripotent stem cell (iPSC) technology, brings strategic leadership to the company. Chief Medical Officer Dr Cai Meng has extensive experience taking innovative therapies from discovery through clinical development, while Chief Quality Officer Ren Xiang is a senior regulatory expert who provides solid support from IND approval to NDA clearance in China, the US, and other countries. Executive Vice President Emmanuel Montet, formerly Vice President of the Asia-Pacific region at Ipsen, now leads iRegene's global business development and international strategy. To accelerate global clinical translation and commercialization, iRegene places great emphasis on the philosophy of 'cooperation and mutual benefit'. At the end of 2021, iRegene entered a long-term collaboration with Danaher Corporation to co-develop next-generation platforms for clinical application. Under this partnership, Danaher will play an active role in developing multi-directional platforms for future iRegene Therapeutics projects. This will involve supplying advanced detection instruments and technical resources relating to life sciences research, the development of effective compounds and screening, multi-omics cell mechanism research, and multi-substance screening. Danaher will help iRegene Therapeutics to enhance the efficiency of platform construction and its ability to deliver practical solutions. Danaher will also support iRegene Therapeutics in developing distinctive, innovative drug pipelines and establishing a research and production base. This strategic cooperation has recently been elevated to the iRegene – Danaher Joint Innovation Center, which is the world's first 'Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems'. The center will focus on integrating artificial intelligence (AI)-driven chemically induced cell therapy R&D with microphysiology systems technology. It is committed to accelerating the clinical translation and application of innovative therapies, and providing patients globally with more precise and effective treatment solutions for diseases. Danaher will fully support iRegene Therapeutics' future planning and development, aiming to jointly advance innovative development in China's life sciences research. iRegene's breakthrough technology platform, strategic advantages and dedicated team have secured continuous support from several leading venture capital firms, with cumulative financing reaching nearly 400 million RMB (55.5 million USD). The company is advancing multiple programs through clinical development, targeting a win-win situation for its products and the capital markets alike, while providing patients around the world with next-generation chemically induced cell therapies that can genuinely reverse disease progression. About iRegene Therapeutics iRegene Therapeutics is a biotechnology company committed to becoming a global leader in universal chemical-induced cell therapy. As one of the first companies to harness AI and + chemical induction for the specific functional modification of cells, iRegene offers a safer, more scalable, and cost-effective alternative to traditional gene or cell therapies. Its pipeline targets diseases with high unmet need, including neurodegenerative disorders such as Parkinson's disease and blindness. Through pioneering science, strategic global partnerships, and a visionary leadership team, iRegene is reshaping the future of regenerative medicine — making advanced therapies accessible to patients worldwide. In August 2023, the NMPA approved the commencement of Phase I clinical trials for iRegene's first product: 'Human Dopaminergic Precursor Cell, NouvNeu001'. This product was developed using the 'AI+ Chem' platform. This made it the world's first chemically induced pluripotent stem cell (iPSC)-derived therapy to enter clinical trials. In June 2024, it was approved by the U.S. FDA for overseas clinical trials. Even more groundbreakingly, in March 2024, iRegene's 'Chemical Induction Platform' became the first system ever to be granted exemption by the FDA. The company's second product, NouvNeu003, which is intended for the treatment of early-onset Parkinson's disease, received NMPA approval in December 2023 and entered Phase I clinical trials. Both NouvNeu001 and NouvNeu003 have now completed Phase I trials. The Phase I results demonstrate good safety, tolerability, and encouraging efficacy in improving motor and non-motor symptoms. The Phase II trial for NouvNeu001 began in April 2025. In parallel, iRegene's first-in-class ophthalmic therapy, was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. Media Contact Company Name: Frost & Sullivan Contact Person: Qian Li Email: Send Email Country: China Website:
Yahoo
a day ago
- Business
- Yahoo
Frost & Sullivan: iRegene Therapeutics Honored as "2025 Forbes China Leading Enterprises in Industry Development"
Shanghai, China--(Newsfile Corp. - June 8, 2025) - Recently, The "2025 Frost & Sullivan China Entrepreneurs Annual Conference and Forbes China Pioneer Innovators in Industry Development Selection Gala Evening of Honor," jointly organized by Frost & Sullivan and Forbes China, was successfully held at Regent Shanghai on The Bund. Amid the global trend of industrial innovation, the results of the "2025 Pioneer Innovators in Industry Development" selection jointly initiated by Forbes China and Frost & Sullivan were officially announced. iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development. iRegene is pioneering the future of regenerative medicine with its AI-powered, chemically induced cell therapy platform. By combining cutting-edge technology, a robust R&D ecosystem, and a globally experienced leadership team, iRegene is redefining allogeneic therapies to make them safer, more effective, and broadly accessible. This recognition highlights iRegene's continued leadership in innovation and its commitment to transforming patient care through next-generation regenerative therapies. iRegene Therapeutics Honored as 2025 Forbes China Leading Enterprises in Industry Development Aroop Zutshi, Global Managing Partner and Executive Board Director of Frost & Sullivan, and Junyi Guo, General Manager of Business Operations at Forbes China, jointly presented the 2025 Forbes China Leading Enterprises in Industry Development award. Dr. Jun Wei, Chairman of iRegene Therapeutics, was invited to attend the gala. AI-Driven Chemical-Induced Cell Therapy: Reshaping the Future of Accessible Cell Therapy Since its establishment in 2017, iRegene Therapeutics has remained committed to addressing unmet clinical needs through the development of next-generation cell therapies. With a focus on chemically induced, universal cell therapy products, iRegene aims to deliver transformative treatments for patients with currently incurable diseases. iRegene Therapeutics has a proprietary, AI-based platform for screening chemical compounds to modify specific cellular functions. The platform leverages induced pluripotent stem cells (iPSCs) to enhance treatment potential. By combining compounds to form a chemically induced culture medium, the "AI+Chem" platform can efficiently and precisely reprogram or optimize a cell's fate and function, thereby enhancing the clinical capabilities of cell therapies. With a focus on the chemical induction system, iRegene has developed a comprehensive research and development (R&D) ecosystem and an international patent system that spans the industry. This ecosystem combines the discovery of 'cell fate determinants', the screening of chemical inducers and the validation of cellular function. The system does not use viral vector construction or transgenic methods; the straightforward CMC procedure is cost-efficient. Furthermore, cell transformation and functional optimization are entirely driven by the cells' natural genetic makeup. Transformation is synchronous under chemically enhanced regulation, eliminating the risk of genetic modification. iRegene's pioneering platform has been proven through the positive outcomes of the Phase I clinical trial. In addition, iRegene's executive team has an international perspective, with all members having successful overseas experience in their specialized fields. CEO Dr Wei Jun is a leading expert in regenerative medicine and the induced pluripotent stem cell (iPSC) technology, bringing strategic leadership to the company. Chief Medical Officer Dr Cai Meng has extensive experience taking innovative therapies from discovery through clinical development, while Chief Quality Officer Ren Xiang is a senior regulatory expert who provides solid support from IND approval to NDA clearance in China, the US, and other countries. Executive Vice President Emmanuel Montet, formerly Vice President of the Asia-Pacific region at Ipsen, now leads iRegene's global business development and international strategy. To accelerate global clinical translation and commercialization, iRegene places great emphasis on the philosophy of 'cooperation and mutual benefit'. At the end of 2021, iRegene entered a long-term collaboration with Danaher Corporation to co-develop next-generation platforms for clinical application. Under this partnership, Danaher will play an active role in developing multi-directional platforms for future iRegene Therapeutics projects. This will involve supplying advanced detection instruments and technical resources relating to life sciences research, the development of effective compounds and screening, multi-omics cell mechanism research, and multi-substance screening. Danaher will help iRegene Therapeutics to enhance the efficiency of platform construction and its ability to deliver practical solutions. Danaher will also support iRegene Therapeutics in developing distinctive, innovative drug pipelines and establishing a research and production base. This strategic cooperation has recently been elevated to the iRegene - Danaher Joint Innovation Center, which is the world's first "Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems". The center will focus on integrating artificial intelligence (AI)-driven chemically induced cell therapy R&D with microphysiology systems technology. It is committed to accelerating the clinical translation and application of innovative therapies, and providing patients globally with more precise and effective treatment solutions for diseases. Danaher will fully support iRegene Therapeutics' future planning and development, aiming to jointly advance innovative development in China's life sciences research. iRegene's breakthrough technology platform, strategic advantages and dedicated team have secured continuous support from several leading venture capital firms, with cumulative financing reaching nearly 400 million RMB (55.5 million USD). The company is advancing multiple programs through clinical development, targeting a win-win situation for its products and the capital markets alike, while providing patients around the world with next-generation chemically induced cell therapies that can genuinely reverse disease progression. About iRegene Therapeutics iRegene Therapeutics is a biotechnology company committed to becoming a global leader in universal chemical-induced cell therapy. As one of the first companies to harness AI and + chemical induction for the specific functional modification of cells, iRegene offers a safer, more scalable, and cost-effective alternative to traditional gene or cell therapies. Its pipeline targets diseases with high unmet need, including neurodegenerative disorders such as Parkinson's disease and blindness. Through pioneering science, strategic global partnerships, and a visionary leadership team, iRegene is reshaping the future of regenerative medicine - making advanced therapies accessible to patients worldwide. In August 2023, the NMPA approved the commencement of Phase I clinical trials for iRegene's first product: 'Human Dopaminergic Precursor Cell, NouvNeu001'. This product was developed using the 'AI+ Chem' platform. This made it the world's first chemically induced pluripotent stem cell (iPSC)-derived therapy to enter clinical trials. In June 2024, it was approved by the U.S. FDA for overseas clinical trials. Even more groundbreakingly, in March 2024, iRegene's 'Chemical Induction Platform' became the first system ever to be granted exemption by the FDA. The company's second product, NouvNeu003, which is intended for the treatment of early-onset Parkinson's disease, received NMPA approval in December 2023 and entered Phase I clinical trials. Both NouvNeu001 and NouvNeu003 have now completed Phase I trials. The Phase I results demonstrate good safety, tolerability, and encouraging efficacy in improving motor and non-motor symptoms. The Phase II trial for NouvNeu001 began in April 2025. In parallel, iRegene's first-in-class ophthalmic therapy, was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. Media Contact Company Name: Frost & SullivanWebsite: PR@ To view the source version of this press release, please visit Sign in to access your portfolio
National Post
02-06-2025
- Business
- National Post
STEMCELL Technologies Announces Acquisition of Cellular Highways
Article content VANCOUVER, British Columbia & CAMBRIDGE, England — STEMCELL Technologies, Canada's largest biotechnology company, is pleased to announce the acquisition of Cellular Highways Ltd from TTP Group Ltd. Cellular Highways is a biotechnology company based near Cambridge, United Kingdom, that specializes in advanced cell sorting technologies with applications in cell and gene therapy, drug discovery, and general cell research, especially where cells are fragile. Article content Article content The acquisition includes the revolutionary Highway1 instrument, which uses Cellular Highways' proprietary VACS™ (Vortex-Actuated Cell Sorting) technology. VACS™ gently and precisely sorts cells and enables high-speed cell sorting in a closed, sterile system through microfluidic vortices. VACS™ uniquely avoids traditional non-sterile droplet-based and electrostatic sorting methods, which can degrade cell health and viability. Highway1 enables researchers and cell therapy developers to process cells more efficiently while maintaining high cell integrity for sensitive applications in research and therapeutic development. This significantly reduces the timelines and costs for research and development. Article content 'Since entering the market in 2024, Highway1 has proven to be the fastest GMP-ready cell sorter available and is designed and manufactured under ISO 13485 certification. We are pleased to welcome this powerful instrument, along with the entire Cellular Highways platform, to STEMCELL's portfolio of advanced cell processing instruments,' said Dr. Allen Eaves, President and CEO, STEMCELL. 'With this new complement to our existing cell isolation and culture product lines, we look forward to further supporting scientists with the tools they need to accelerate innovation in the development of life-changing cell and gene therapies.' Article content Current Highway1 customers will receive continued technical support from STEMCELL's dedicated team of Product and Scientific Support specialists. Article content 'Cellular Highways customers are in great hands with STEMCELL—a major player in the global biotechnology industry with a stellar reputation for its best-in-class products and customer service,' said Dr. Alex Jones on behalf of Cellular Highways. 'With STEMCELL's global reach, we are excited that this acquisition will help introduce Highway1 to even more labs around the world.' Article content 'The acquisition is a testament to Cellular Highways' exceptional team and innovation. With STEMCELL's reputation and global reach, it is ideally positioned to thrive in the rapidly growing research and cell therapy manufacturing markets,' said Dr. Sam Hyde, CEO of TTP. 'For TTP Group, this demonstrates our unique ability to build and nurture businesses that deliver breakthrough technologies, transform them into market-leading products, and create significant value.' Article content 'This acquisition aligns with STEMCELL's strategic growth in the cell therapy space,' said Dr. Eaves. 'With this enhanced ability to support cutting-edge research and biomanufacturing workflows, we will continue to help the scientific community advance research and make discoveries with greater speed and accuracy.' Article content About STEMCELL Technologies STEMCELL Technologies supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, educational resources, and contract assay services that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally. Article content About TTP Group TTP Group is an independent technology company where scientists and engineers collaborate to invent, design, and engineer breakthrough technologies and products. Working across sectors including healthcare, life sciences, communications, and industrials, TTP combines deep technical expertise with commercial insight to deliver innovations that drive progress and create value. Founded in 1987, TTP Group develops technologies and products for clients worldwide and nurtures high-impact venture businesses. Article content About Cellular Highways Cellular Highways was founded to take fluorescence-based cell sorting into new therapy development and research applications, requiring fast, gentle, sterile, scalable cell sorting, using the unique potential of the VACS™ technology. Cellular Highways span out from TTP Group. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
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
