Cell Therapy and Cryopreservation

Standardize cell therapy discovery, development and manufacturing.

 

Standardize multiple points in the cell therapy workflow from cell preparation, to freezing, transport and thawing.

 

Controlled-Rate Freezing

 

CoolCell® cell freezing containers provide demonstrated, controlled-rate freezing without the need for alcohol or expensive, dedicated equipment such as controlled-rate freezers. CoolCell cell freezing containers come in a range of sizes to fit both autologous and allogeneic therapies, and are adaptable for most cell types. There are several steps in the cell therapy process that may require cell freezing including generation of master cell bank, working cell bank and final cell therapy product.

 


TxCell integrates CoolCell into their Treg clinical trial

In a feasibility study for their Ovasave® clinical trials, France-based TxCell, SA determined CoolCell cell freezing containers performed equivalent to a controlled-rate freezer (CRF) for the development of of their cell therapy products. (Figure 1).  Because CoolCell is adaptible to a GMP environment (Figure 2) considerably easier to deploy to clinical sites, is more cost-effective and requires no maintenance, it was adopted over a CRF for the Ovasave phase 2b trial.

coolcell equivalent to crf treg     coolcell equivalent to crf treg
Fig 1.  CoolCell performance compared to a controlled-rate freezer 
Performance test: Effects of freezing on antigen-specific Treg (Ag-Treg) cell therapy products; Ag-Tregs (n = 6) were frozen at a concentration of 1 to 10 × 106 cells/mL using the CoolCell freezing device or programmable freezer (freezing rate of –1 °C/min). Viability and absolute viable cell count of thawed Ag-Treg cell therapy products were evaluated by flow cytometry. (Data generated by TxCell, SA)
   
Fig 2.  Particle release performance data  
Particle release performance was tested three times on three different CoolCell freezing devices (nine measurements). Upper line on each graph indicates maximum acceptable particle count for each particle size measured. The CoolCell device is suitable for use in an active GMP cleanroom. 
(Data generated by TxCell, SA)

 

 

Cold Chain Management

 

Transport samples stored in liquid nitrogen

Liquid nitrogen-based CryoPod™ Carrier provides up to 4 hours of < -150°C temperature stability for valuable biological specimens and other materials.  Ideal for transporting between buildings or around metro areas, the portable, compact carrier features an absorbent that prevents LN2 movement, minimizing risk of LN2 exposure to the specimens and operator.  The electronic panel displays temperature, date and time and features audible and visual alarms, and logging capabilities.  An optional automated filling station quickly and safely replenishes the 3L LN2 charge for extended operations.