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The University of Southampton
Cancer Research UK Centre

Good Manufacturing Practice (GMP) Facility

The University of Southampton's GMP Facilities primary role is to support the manufacturing for Translational Research associated with Phase I/II clinical trials, on a project campaign basis. Technologies in this area are rapidly evolving and cutting edge procedures to develop novel therapies are being undertaken. Our facility provides the technical and practical support for production under this highly regulated environment.

Facilities currently include: Unit 1 -Dave Wellman GMP Facility within the Cancer Sciences Division with an additional second site Unit 2 -NBS GMP Translational Research Laboratory, available late 2007. These purpose built facilities were designed with flexible functionality for the manufacturing of small scale aseptic Investigational Medicinal Products (IMPs) of translational Research Biologicals for Phase I/II clinical trials.

We offer fully quality controlled and monitored Grade A production areas within Grade B clean room environments. Our clean room facility is fully licensed under MHRA which permits the authorization to manufacture and assemble investigational medicinal products for human use in accordance with clinical trials regulations. License authorisation allows for production of sterile, non sterile and aseptically prepared products. Potential classes of products currently authorised under the license include vaccines, blood and blood derivatives, immune sera, cell therapy, gene therapy, recombinant DNA and cytokines.

A recent project involved the manufacture of a patient specific vaccine produced from GMO transfected Dendritic Cells. Process involved WBC harvested from a patients blood by leukapheresis. These were purified on the CliniMACS system for positive monocyte selection. Target cells were then incubated with growth factors and cultured prior to a Viral tranfection step, The transfected DC were then washed and frozen for future patient vaccination (post stringent quality control checks).
We are part of the translational group and are available for discussion.

For more information contact Kathy Potter.

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