News

CaseBioscience® announced the launch of two innovative products designed to advance clinical cell therapy development: CaseCryo® CTG DMSO, a cutting-edge cryopreservation solution, and CaseStor® HSS Hypothermic Storage Solution, tailored for controlled storage of cells and tissues at low temperatures. This product line marks an expansion of CaseBioscience's biopreservation portfolio at Advanced Therapies Week (ATW) 2026. In combination, these solutions highlight the company's commitment to delivevring high-quality, reliable solutions that address the intricate needs of sensitive cell therapy workflows.

Quality and Compliance at the Core of Manufacturing

Both CaseCryo® CTG DMSO and CaseStor® HSS are manufactured under stringent, cGMP-aligned conditions, housed within an FDA-registered facility certified to ISO 13485:2016 standards. The company applies rigorous regulatory and quality principles drawn from highly controlled assisted reproductive technology (ART) workflows, ensuring the highest levels of consistency and safety. To further support clinical use, Drug Master Files (DMFs) have been submitted, facilitating streamlined development and manufacturing of cell therapy products.

A Systems-Level Approach to Cryopreservation and Storage

CaseCryo® CTG DMSO is designed with a comprehensive, systems-level perspective, recognizing cryopreservation as an interconnected, end-to-end process. This approach aims not only to maintain immediate post-thaw viability but also to support sustained cell survival, functional performance, and consistency throughout manufacturing. Complementing this, CaseStor® HSS offers a specialized solution for the hypothermic storage of cells and tissues, addressing the varied requirements of diverse cell therapy workflows that rely on controlled, low-temperature storage.

Demonstrated Benefits for Long-Term Cell Health and Functionality

Extensive evaluations of these novel biopreservation products reveal their promise in enhancing long-term cell health and performance. CaseStor® HSS has been shown to significantly improve the post-storage expansion capabilities of critical cell types such as human pluripotent stem cells (hPSCs), T cells, and mesenchymal stem cells (MSCs). Meanwhile, CaseCryo® CTG DMSO delivers superior outcomes for long-term recovery and expansion of T cells and hPSCs when benchmarked against leading commercial cryopreservation solutions. These results embody CaseBioscience’s commitment to a holistic biopreservation strategy that extends beyond mere viability to ensure enduring functional success throughout the entire cell therapy development and manufacturing cycle.

Commitment to Clinical-Grade Cell Therapy Solutions

Kevin Flynn, PhD, Chief Scientific Officer at CaseBioscience®, emphasizes the critical role of cryopreservation and hypothermic storage in enabling effective cell and tissue therapies. He notes that CaseCryo® CTG DMSO and CaseStor® HSS are purpose-built for clinical applications, prioritizing long-term cell quality, performance, and adherence to regulatory standards. This focus ensures that the evolving needs of the cell therapy field are met with robust, clinically relevant biopreservation products.

Expanding the Portfolio and Advancing Research

These new offerings complement CaseBioscience’s existing suite of cell therapy research products, including CaseCryo® DMSO, CaseCryo® NON-DMSO, CaseBase® Washing Medium, and CaseBase® Dissociation Medium. The company continues to innovate, with additional formulations such as CaseCryo® CTG NON-DMSO—intended for clinical use—progressing through development. These efforts reflect a broader mission to explore alternative cryoprotectant strategies and enhance preservation techniques for emerging cell therapy applications.

Leading the Way with AI-Driven Biopreservation Research

CaseBioscience’s commitment to innovation extends into research, as recently showcased at the ISSCR PSC-Derived Therapies Symposium. There, the company presented a poster titled "An AI-assisted literature screening approach identifies potential DMSO-free cryoprotectants for optimal preservation of human Pluripotent- and Neural- Stem Cells." This pioneering work highlights the company’s forward-thinking approach, leveraging artificial intelligence to discover next-generation biopreservation solutions that support the evolving landscape of cell therapy modalities.