Latest news with #RubyTsai
Yahoo
20-05-2025
- Business
- Yahoo
Applied StemCell Launches Two New Hypoimmunogenic hiPSC Products to Accelerate Allogeneic Cell Therapy Development
MILPITAS, Calif., May 20, 2025--(BUSINESS WIRE)--Applied StemCell, a CRO/CDMO that blends unique genome editing technology and iPSC expertise, announced the launch of their first hypoimmunogenic hiPSC products which are designed to empower researchers developing next-generation allogeneic cell therapies. The ActiCells™ RUO Hypo hiPSCs (Cat.# ASE-9550) and the ActiCells™ RUO TARGATT™ Hypo hiPSC Knock-in Kit (Cat.# AST-9650) offer powerful tools for building off-the-shelf therapies by combining reduced immunogenicity, robust pluripotency, and genome engineering readiness. They are an isogenic match to the forthcoming GMP-grade versions to offer a seamless path from early research to clinical development. Both new research-use-only (RUO) products are reprogrammed from CD34+ umbilical cord blood cells—selected for their low mutational burden and reduced immune activation—and genetically modified to knock out both B2M and CIITA, eliminating cell surface expression of HLA class I and II molecules. This B2M/CIITA double knock-out minimizes the likelihood of T cell-mediated immune rejection, accelerating your allogeneic therapeutic development. "Our latest ActiCells products demonstrate how Applied StemCell's deep expertise in iPSC biology and genome editing enables us to create tools that push the boundaries of what's possible in allogeneic therapy," said Ruby Tsai, Ph.D., CEO of Applied StemCell. "With these new hypoimmunogenic iPSC platforms, researchers have the flexibility to rapidly build, test, and optimize cell therapies that are designed to evade immune rejection." The ActiCells™ RUO Hypo hiPSCs product provides a ready-to-use, transgene-free cell line that is well-characterized, pluripotent, and ready for additional genome engineering. For researchers who require immediate knock-in capabilities, the ActiCells™ RUO TARGATT™ Hypo hiPSC Knock-in Kit includes the same hypoimmunogenic cell line pre-engineered with TARGATT™ large knock-in technology at the H11 safe harbor locus. The kit also includes cloning and integrase plasmids, enabling site-specific insertion of payloads up to 20 kb with reliable expression and minimal risk of gene silencing or off-target effects. "These two complementary products allow researchers to choose the format that best fits their project timelines and resources," said Dr. Tsai. "Whether you're building custom engineered lines in your own lab or partnering with us for iPSC gene editing services, you can count on ActiCells to deliver consistent quality and advanced functionality." For more information, visit: About Applied StemCell Founded in 2008 to provide industry and academic researchers with the ability to leverage the power of induced pluripotent stem cells (iPSC) and gene editing, Applied StemCell continues to use our innovative technologies to power the discovery and development of advanced therapeutics. Our products and services enable the full spectrum of basic research to GMP manufacturing—including disease modeling, iPSC services, mammalian cell line engineering, and nonclinical and pre-IND studies—and our patented technologies ensure a clear IP path to commercialization. View source version on Contacts Media Contact: Pia AbolaDirector of MarketingApplied (408) 457-1312 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
20-05-2025
- Business
- Business Wire
Applied StemCell Launches Two New Hypoimmunogenic hiPSC Products to Accelerate Allogeneic Cell Therapy Development
MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, a CRO/CDMO that blends unique genome editing technology and iPSC expertise, announced the launch of their first hypoimmunogenic hiPSC products which are designed to empower researchers developing next-generation allogeneic cell therapies. The ActiCells™ RUO Hypo hiPSCs (Cat.# ASE-9550) and the ActiCells™ RUO TARGATT™ Hypo hiPSC Knock-in Kit (Cat.# AST-9650) offer powerful tools for building off-the-shelf therapies by combining reduced immunogenicity, robust pluripotency, and genome engineering readiness. They are an isogenic match to the forthcoming GMP-grade versions to offer a seamless path from early research to clinical development. 'With these new hypoimmunogenic iPSC platforms, researchers have the flexibility to rapidly build, test, and optimize cell therapies that are designed to evade immune rejection.' Both new research-use-only (RUO) products are reprogrammed from CD34+ umbilical cord blood cells—selected for their low mutational burden and reduced immune activation—and genetically modified to knock out both B2M and CIITA, eliminating cell surface expression of HLA class I and II molecules. This B2M/CIITA double knock-out minimizes the likelihood of T cell-mediated immune rejection, accelerating your allogeneic therapeutic development. 'Our latest ActiCells products demonstrate how Applied StemCell's deep expertise in iPSC biology and genome editing enables us to create tools that push the boundaries of what's possible in allogeneic therapy,' said Ruby Tsai, Ph.D., CEO of Applied StemCell. 'With these new hypoimmunogenic iPSC platforms, researchers have the flexibility to rapidly build, test, and optimize cell therapies that are designed to evade immune rejection.' The ActiCells™ RUO Hypo hiPSCs product provides a ready-to-use, transgene-free cell line that is well-characterized, pluripotent, and ready for additional genome engineering. For researchers who require immediate knock-in capabilities, the ActiCells™ RUO TARGATT™ Hypo hiPSC Knock-in Kit includes the same hypoimmunogenic cell line pre-engineered with TARGATT™ large knock-in technology at the H11 safe harbor locus. The kit also includes cloning and integrase plasmids, enabling site-specific insertion of payloads up to 20 kb with reliable expression and minimal risk of gene silencing or off-target effects. 'These two complementary products allow researchers to choose the format that best fits their project timelines and resources,' said Dr. Tsai. 'Whether you're building custom engineered lines in your own lab or partnering with us for iPSC gene editing services, you can count on ActiCells to deliver consistent quality and advanced functionality.' For more information, visit: About Applied StemCell Founded in 2008 to provide industry and academic researchers with the ability to leverage the power of induced pluripotent stem cells (iPSC) and gene editing, Applied StemCell continues to use our innovative technologies to power the discovery and development of advanced therapeutics. Our products and services enable the full spectrum of basic research to GMP manufacturing—including disease modeling, iPSC services, mammalian cell line engineering, and nonclinical and pre-IND studies—and our patented technologies ensure a clear IP path to commercialization.
Yahoo
14-04-2025
- Business
- Yahoo
Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line
MILPITAS, Calif., April 14, 2025--(BUSINESS WIRE)--Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its ActiCells™ GMP Human Induced Pluripotent Stem Cell (hiPSC) line. This milestone underscores the company's commitment to empowering scientists to accelerate their cell therapy development by providing high-quality, regulatory-compliant iPSC solutions. In addition to its ActiCells GMP hiPSC line, Applied StemCell is introducing a powerful iPSC line pre-engineered with their patented TARGATT™ landing pad at the H11 safe harbor locus. This innovation enables precise, site-specific insertion of as much as 20 kb of DNA in a single reaction, allowing for consistent, reliable expression of one or more genes. By combining GMP compliance with TARGATT™ technology, Applied StemCell offers cell therapy developers an efficient and scalable solution for engineering iPSCs to meet their specific therapeutic needs. "Securing a DMF for our ActiCells GMP hiPSC line, along with introducing our ActiCells GMP TARGATT™ hiPSC Knock-in Kit, represents a major advancement for the cell therapy industry," said Ruby Tsai, Ph.D., CEO at Applied StemCell. "By providing a fully characterized, regulatory-ready iPSC platform, we empower researchers to accelerate development while reducing manufacturing and regulatory hurdles." Applied StemCell's GMP iPSC solutions support a wide range of regenerative medicine and cell-based therapy applications. With the added advantage of a pre-engineered TARGATT™ landing pad, developers can efficiently generate gene-edited cell lines with high efficiency and reproducibility, expediting the path to clinical and commercial success. For more information on how Applied StemCell's ActiCells GMP hiPSC line can advance your therapeutic development, please visit or contact Pia Abola, Ph.D., Director of Marketing at Applied StemCell. About Applied StemCell Founded in 2008 to provide industry and academic researchers with the ability to leverage the power of induced pluripotent stem cell (iPSC) technology, Applied StemCell continues to use their innovative technology to power autologous and allogeneic discovery and development. Their products and services enable a full spectrum of studies from basic research to GMP manufacturing and biobanking—including disease modeling, library construction, drug screening, and nonclinical and pre-IND mouse studies—and their patented technologies ensure a clear IP path to commercialization. View source version on Contacts Media Contact: Pia AbolaDirector of MarketingApplied +1 (408) 457-1312 Sign in to access your portfolio
