Cell Thawing Systems: De-risk cell thawing with the ThawSTAR system
Standardized, reproducible thawing for all cell types
Problem: Manual cell thawing methods are unstandardized and are generally not accepted in a clinical environment, where point-of-care methodology must meet GxP regulatory requirements.
- Contamination risk from thawing in a water bath
- Variable end points can introduce unwanted changes in therapeutic potency
- Not standardized to meet GMP requirements
- Differences in user technique may skew downstream clinical results
Solution: Cell thawing with ThawSTAR replaces variable methods allowing use in early R&D phase and straightforward scalability to commercial manufacturing and point-of‑care. Fully automated and easy to use, ThawSTAR virtually eliminates human error from the thawing equation.
- Ideal for thawing cells in a GMP facility, facilitates point-of-care use
- De-risk cell handling during therapeutic cell thawing
- Controlled profile thawing for predictable therapeutic efficacy
- Highly reproducible thaw profiles across multiple clinical sites
- Removes subjectivity and variability when thawing cells at point of care
How ThawSTAR® works
Off-the-Shelf IOP Qualification Package ThawSTAR® CFT2 Automated Cell Thawing System
- Comprehensive qualification documentation makes therapeutic cell thawing easy to authenticate
- Testing accessories included with Qualification Packet
- Step-by-Step IOPQ protocol and report templates for thawing in a controlled environment
- Based on GxP industry standards / GAMP® 5 methodology
Enables incorporation of ThawSTAR® into clinical studies MAF on file with FDA (reference number MAF2643) containing information on all models of ThawSTAR the Master File for ThawSTAR® Automated Cell Thawing System has been registered to the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) under the reference number MAF2643. If you are submitting an investigational new drug (IND) application or a biologics license application (BLA) to the U.S. FDA, and need a cross-reference letter to our Master File, please contact us at firstname.lastname@example.org.
ThawSTAR® Performance Data
ThawSTAR® AT6 Thaw Time Reproducibility
ThawSTAR® AT6 thaw time reproducibility using an optimized algorithm, thaw times are highly reproducible from unit to unit for each fill volume tested and from liquid nitrogen or dry ice temperatures. Thaw times for 17 pre-production AT6 units. 6 ml vials were filled with 2-6 ml of cryopreservation solution, and each volume was thawed in 17 units over 1 week of testing. Thaw times were about 50 s longer when starting from liquid nitrogen temperatures.
Ex-Vivo B Cells: Cell thawing with ThawSTAR vs. water bath
Post-thaw viability and consistency were evaluated using a total of 6 vials (2 each from 3 donors) containing ex vivo stimulated B cells, were frozen in a -80°C freezer using a CoolCell® cell freezing container and then stored in liquid nitrogen for two weeks. One vial from each donor was removed from LN2, placed into a ThawSTAR® CFT2 Transporter and thawed in a ThawSTAR CFT2 Instrument. The other vial from each donor was removed from LN2 and hand-carried to a water bath. The vials transported and thawed in the ThawSTAR transport and thawing system performed better in terms of cell viability and recovery.
— Data generated by UCSF Diabetes Center and Transplant Surgery
PBMC Cell Recovery and Consistency
Mean recovery is compared for paired PBMCs isolated immediately after phlebotomy using traditional Ficoll and SepMate methods (left) (n = 6). Mean recovery post cryopreservation is compared for paired PBMCs isolated immediately after phlebotomy for cells thawed in a water bath and using the ThawSTAR CFT2 Instrument (right) (n = 3).
— Data generated by Blood Systems Research Institute
Higher Post-Rest PBMC Recovery
Post-rest cell counts were measured using trypan blue exclusion on a hemocytometer. Post rest recovery is measured at 16-20 hours post-thaw. n=10 donors, processed in 6 runs * p ≤ 0.05 (p = 0.0333).
— Data courtesy of Alexandra Kolanitch, Caprion Biosciences
ThawSTAR Cell Thawing System Case Studies
DiscoverX Cell Services Facility Adopts ThawSTAR® Automated Cell Thawing System into their BioAssay and Cell Profiling Workflow
“Both of my teams solely use the ThawSTAR® system as their go to thawing device for thawing cells. It is second to none when it comes to efficiency, consistency and sterility. If we have high quality, robust cells, they tend to recover better, propagate better and, overall, perform better in assay. I look forward to using our ThawSTAR® system for many years to come.”
CPMC’s Liver Disease and Transplantation Program Adopts ThawSTAR® Automated Cell Thawing System for Use in Biorepository Sample Quality Control and Cellular Immunology
“Often investigators ask how the cells are prepared and thawed. By including the ThawSTAR® method in our SOPs, we inform them of the best way to handle the cells to ensure maximal recovery.”
Celavie Biosciences Adopts Automated Cell Thawing System for their Neural Stem Cell Therapy Program
“The ThawSTAR® system was small, easy to use, and totally automated. It exceeded my expectations. I was happy with how reliable the results were, and how it eliminated the risk of contamination.”
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