Cell therapy weekly: GMP certification of iPSC-focused manufacturing facility
This week: NewBiologix (Épalinges, Switzerland) launched the Xcell™ recombinant adeno-associated viruses (rAAV) production and analytics platform, Alloy Therapeutics (MA, USA) announced a collaboration with Takeda Pharmaceuticals (London, UK) to advance cell therapy platforms using induced pluripotent stem cells (iPSCs) and Cellistic (Gosselies, Belgium) announced the successful audit and GMP certification of its iPSC-focused manufacturing facility.
The news highlights:
- New rAAV production and analytics platform launched
- A cell therapy platform leveraging iPSCs
- GMP certification of iPSC-focused manufacturing facility
New rAAV production and analytics platform launched
NewBiologix has launched the Xcell rAAV production and analytics platform to simplify and speed up the production of rAAVs for gene and cell therapy. At its core is the Xcell Eng-HEK293 cell line, a specially designed and fully characterized system that is fine-tuned for producing high-quality rAAVs using transient transfection.
This platform provides a complete solution, from DNA synthesis to rAAV production, allowing companies to test multiple rAAV candidates at the same time. This approach helps cut down development time and costs while also reducing risks. The platform’s built-in tools ensure quality by analyzing key factors like full-to-empty capsid ratios, gene sequence integrity and contaminant DNA. With its clinical-grade purification process, it delivers rAAVs that meet strict regulatory standards.
Igor Fisch, CEO of NewBiologix, stated: “NewBiologix created the Xcell rAAV platform to support the fast-evolving gene therapy field by reducing rAAV candidate production timelines while improving quality. Our integrated and comprehensive platform helps minimize production risks, facilitating more efficient advancement of gene therapies to the clinic.”
A cell therapy platform leveraging iPSCs
Alloy Therapeutics has teamed up with Takeda Pharmaceutical to advance cell therapy platforms using iPSCs. This collaboration focuses on developing Takeda’s iCAR-T and iCAR-NK platforms, designed to create potent “off-the-shelf” cell therapies for treating solid and hematological cancers. These platforms aim to improve performance, reduce manufacturing costs and provide scalable alternatives to traditional autologous cell therapies. Under the agreement, Alloy gains shared commercialization rights for iCAR-T and iCAR-NK products targeting cancer.
“iCAR-T is one of our flagship projects graduating from T-CiRA, our decade-long joint research program between Takeda and [Center for iPS Research and Application (CiRA)]. This agreement between Takeda and Alloy aims to advance iCAR-T from discovery to clinical development,” said Yasushi Kajii, Head of research and development, Japan Region, at Takeda. “We are impressed with Alloy’s corporate culture of valuing platform technologies, flexibility in collaboration, patient-centric mindset, and company creation abilities, all of which were key elements to our decision to work with Alloy. We look forward to seeing iCAR-T and iCAR-NK blossom as the technology advances to its next phase.”
GMP certification of iPSC-focused manufacturing facility
Cellistic has achieved GMP certification for its facility dedicated to manufacturing off-the-shelf cell therapies based on iPSCs. Certified by Belgium’s Federal Agency for Medicines and Health Products under EMA guidelines, this milestone highlights Cellistic’s readiness to meet rigorous quality and regulatory standards. With nearly 15 years of GMP manufacturing experience, the facility has been transformed into a cutting-edge center exclusively focused on iPSC-based allogeneic therapies.
The facility offers a fully integrated setup, including areas for open and closed cell manufacturing, fill-and-finish cryopreservation, quality control, packaging and warehousing. As part of its Echo platform, Cellistic has implemented iPSC-based processes using stirred tank bioreactors, enabling scalable and cost-effective production to significantly lower therapy costs.
