Whitley GMP Processing Suite

Case Study

An isolator is required by a customer engaged in clinical stage biopharmaceuticals, developing innovative cancer immunotherapy products based on a T-cell receptor platform that helps to identify cancer targets. This high-risk cell processing requires maintaining a safe and contamination free environment that allows the completion of a large portion of the processing without removing cell samples from a precisely controlled environment.

The Whitley GMP Processing Suite provides an environment in which to carry out the modification of stem cells and differentiation of these cells to create T-cells to introduce back into the patient's body via an accessible solution that will aim to alter the body's own immune system to fight their cancer.

A bespoke GMP Processing Suite allows cell manipulation and incubation to be carried out in a Grade A isolator without the risk of contamination during transference. This system also includes the ability to decontaminate all areas of the suite, including the airlocks that are used to transfer consumables into the system. As a completely closed, re-circulating, isolator system with VHP decontamination, this suite could be used in a Grade D background. This is a cost-effective method compared with traditional cell manipulation that is usually conducted inside a Grade A open biological safety cabinet in a Grade B background with a separate incubator and a strict cleaning process between transferences. The GMP Processing Suite is a very cost-effective solution.