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Whitley GMP Processing Suite
The Whitley GMP Processing Suite (WGMPPS) is a modular system combining different GMP Workstations and Isolators to suit the needs of your process. As well as having the choice of two sizes of standard airlock (17.5 or 43 litres), H135s and H155s can be joined together with specially designed 3-way airlocks to provide a customised processing suite for ATM production.
For example, you may require an incubation area, a refrigeration section to store media, and a 'high risk' cell processing area that would work together to allow manipulation in a safe, controlled, and contamination free environment. DWS will work with you throughout the design, specification, build and installation stages to ensure the Processing Suite is ideal for your particular application.
VHP Decontamination
If required, DWS can incorporate a vaporised hydrogen peroxide (VHP) decontamination system - such as the Steris M100-S - into your Processing Suite.
Validation Documentation Packages
Customers who work to GMP processes can rest assured that they don't have to source their own external, specialist organisations to perform these important tests once their workstation has been installed, as DWS has experience of conducting these tests on behalf of customers. Documentation includes functional specification, factory acceptance tests, site acceptance tests, installation qualification, operational qualification, and periodic re-qualification. Additional optional OQ GMP tests include DOP, HEPA filter face velocity, smoke pattern, non-viable particle counts, UKAS temperature mapping, pressure decay verification, and software system verification.
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.
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