| Isothermal shield

The unique insulator to prevent protein aggregation and container damage caused by pressure.

Fig. 1 – SmartFreezCRYO Isothermal Shield.
The insulator with phase-change material is placed at the top of the bottle. It covers the top of the bottle leaving the bottom exposed to the external conditions.

  • Improves freeze-thawing quality of biologic drug substances
  • Can be manufactured for different bottle sizes and shapes
  • Easy to remove and reuse

SmartFreezCRYO

Isothermal Shield

Without the Isothermal Shield the top of the liquid freezes rapidly, forming an ice-crust that encloses the remaining liquid phase, causing the pressure of the confined liquid to increase.

The entrapped liquid phase is therefore pushed throughout the ice-crust, causing a mound-like structure at the top (Fig. 2). Air bubbles are typically entrapped within the ice-crust forming a foamy-like ice structure presenting a higher interfacial tension.

Fig. 2 – Isothermal Shield performance at -80 °C, using a 0.5 L bottle with a 10% (w/w) sucrose solution. On the left hand side is shown the result with the Isothermal Shield (evidencing the flat interface) and on the right hand side is shown the result obtained without the Isothermal Shield (with an ice-mound on the top).

Reducing aggregation

Isothermal Shield improves protein stability.

Comparison between bottles with and without Isothermal Shield.

The images show, from left to right:

  1. the Magnetic Ressonance Imaging (MRI) of the ice matrix;
  2. the local concentration of protein (defined as C/C0), measured after sampling from the frozen solution;
  3. the local variation of Δ% of aggregates (relative to initial solution before freezing).