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

IOP Qualification

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

Master File

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 regulatory@medcision.com.

ThawSTAR® Performance Data

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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.

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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

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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

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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

Applications

ThawSTAR Cell Thawing System Case Studies


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