Islet isolation under cGMP conditions: replacing the coil

Area of Science:

• Biomedical Engineering
• Cellular Therapy
• Transplantation Science

Background:

• Clinical islet transplantation is increasingly regulated under current good manufacturing practices (cGMP).
• cGMP mandates validation of equipment cleaning and sterilization.
• Current automated islet isolation uses a metal coil requiring complex cleaning and sterilization.

Purpose of the Study:

• To assess a disposable blood warming system as a cGMP-compliant alternative to metal coils.
• To evaluate the system's flow rate accommodation during pancreatic digestion.
• To determine the system's heat exchange efficiency and temperature control capabilities.

Main Methods:

• A pancreas digestion circuit was established using either a metal coil or a disposable Warmflo blood warming bag.
• Temperature within the digestion chamber was monitored using a thermocouple.
• Time to reach 37°C and temperature maintenance were recorded at various set temperatures.

Main Results:

• The disposable blood warming bag accommodated flow rates of 150 and 300 mL/min.
• The bag achieved 37°C in shorter or equivalent time compared to the metal coil.
• Temperature maintenance was equivalent, with successful application in four human islet isolations.

Conclusions:

• A disposable blood warming system offers adequate flow, heat exchange, and temperature control for islet isolation.
• This system may simplify compliance with current good manufacturing practices (cGMP).
• Facilitates the advancement of islet isolation processes toward regulatory standards.