Reactor-Ready used to manufacture GMP compliant polymer for medical applications

Scientists at University College London are creating ears made out of polyurethane-type polymers, to be implanted onto children with severe disfigurements in the first clinical trial of its kind. The scientific team has been testing the process by implanting an ear on a rat.

The operation is a major medical breakthrough and could radically change organ transplants. Professor Seifalian’s Group at University College London and Royal Free Hospital were involved in the synthesis of the polymers by solution polymerisation.

Importantly, for polymer production to become GMP compliant, the synthesis protocol needed to be validated, however, this wasn’t possible using conventional off-the-shelf heating mantles and quick-fit apparatus as they introduced too many inconsistencies in the manufacturing process, for example, the temperature was very difficult to control at the pre-polymer stage, glass flanges needed silicone grease, PTFE gaskets were difficult to fit in place and the connection of the stirring paddle to the overhead stirring motor was difficult to set up.

The Reactor-Ready lab reactor offered solutions to the equipment problems described above and the Huber Ministat has enabled better temperature control. This means that the group has been able to achieve a GMP-compliant process at a specialised facility – Stevenage Bioscience Catalyst. The process is better controlled and producing a more consistent product.