# Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products

> **NIH NIH R44** · CRYOCRATE, LLC · 2022 · $898,913

## Abstract

SUMMARY
Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a first-
in-class biocompatible cryopreservation medium product that doesn’t need any cell permeating and toxic
cryoprotectant. The product is trademarked as OdinSol®, and has been approved to provide significantly
improved efficiency in cryostorage of cell types that are essential for cell-based adoptive immunotherapies. The
OdinSol® technology also removes the requirement of serum and human products and secures long-term storage
in regular -80oC deep freezers.
Based on our former experience in FDA 510(k) submission, in this project, we organized the collaboration with
our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan), contract research
organization (WuXi AppTec), academic subcontract collaborator (the Center for Precision Medicine at University
of Missouri), to achieve the following milestones:
I. The production of OdinSol® meets GMP qualifications and biocompatibility assessment shows
 compliance with FDA guidance for 510(k) submission as a storage device for transfusable cells;
II. The in vitro and in vivo evaluation of safety and efficacy demonstrates the OdinSol® technology to be
 superior to existing cryopreservation protocols with respect to preserving viability and functionalities
 of T, NK and CAR-T cells;
III. Based on those qualifications, we will complete of the 510(k) submission and finalize of the production
 line based on further FDA feedback before the end of the project period.
We expect future clinical use of the OdinSol® technology within three years after the FDA clearance, providing
the industry of cell therapies with a highly efficient biocompatible cryostorage platform.

## Key facts

- **NIH application ID:** 10611789
- **Project number:** 1R44CA278579-01
- **Recipient organization:** CRYOCRATE, LLC
- **Principal Investigator:** Xu Han
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $898,913
- **Award type:** 1
- **Project period:** 2022-09-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10611789

## Citation

> US National Institutes of Health, RePORTER application 10611789, Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products (1R44CA278579-01). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10611789. Licensed CC0.

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