Miltenyi BioIndustry achieves first clinical CAR-T cell production with lentiviral vector
[by Ji, Yong Jun] Verismo Therapeutics (hereafter referred to as Verismo), the U.S. subsidiary of HLB Innovation, announced on September 25 that preparations for its production infrastructure supporting SynKIR-110, a chimeric antigen receptor T-cell (CAR-T) treatment for solid tumors, are progressing on schedule, in line with plans for Phase 2 clinical trials and future commercialization.
스피드 바카라 recently completed the successful production of its first clinical CAR-T treatment candidate utilizing a lentiviral vector supplied by Miltenyi BioIndustry, the dedicated contract development and manufacturing organization (CDMO) of Miltenyi Biotec (hereafter referred to as Miltenyi), a global leader in cell and gene therapy (CGT) infrastructure.
The company had earlier entered into a partnership with Miltenyi BioIndustry to secure a reliable supply of GMP (Good Manufacturing Practice)-grade lentiviral vectors essential for the production of SynKIR-110, a CAR-T therapy candidate advancing toward Phase 2 clinical trials.
스피드 바카라 showcased its development capabilities by successfully achieving stable production of clinical-grade CAR-T therapy candidates while maintaining active communication with the U.S. Food and Drug Administration (FDA), even amid manufacturing process adjustments, including changes to the lentiviral vector.
Miltenyi BioIndustry is a global player supporting clinical trials of gene-edited cell therapies, with capabilities spanning from research-stage design to the manufacturing and GMP-scale production of lentiviral vectors. 스피드 바카라 emphasized that its collaboration with Miltenyi holds particular significance, as it not only secured a stable vector supply chain for late-stage clinical trials and commercialization but also establishes an optimized production system aligned with global regulatory standards.
"Our collaboration with Miltenyi BioIndustry is central to the expansion of our program. This partnership underscores our commitment to ensuring manufacturing continuity and advancing readiness for Phase 2 clinical trial," said Dr. Bryan Kim, co-Founder and CEO of HLB Innovation and 스피드 바카라.
“We are proud to continue supporting 스피드 바카라’s research through our viral vector platform,” stated Stefan Miltenyi, founder and CEO of Miltenyi. “스피드 바카라’s innovative approach to next-generation CAR-T therapies is well aligned with our mission and goals,” he added.