New 50L GMP Plasmid Stream, Keele

The Opportunity

Charles River Laboratories (CRL) Stephenson Building is situated within the Keele University Campus. This facility supports the development and manufacturing of cell and gene therapy in the form of plasmid DNA for clinical and commercial supply.

The facility has over 145 staff and is made up of c. 1400m² of manufacturing and 300m² of warehouse space. The manufacturing space has 10+ ISO 7 Grade C production suites in two manufacturing areas. All areas have HEPA-filtered HVAC and operations are product specific.

CRL had the urgent need to upgrade the existing (Phase 1) RNAse-free 50L process within the Stephenson Building by repurposing existing cleanrooms in the facility to create one additional (Phase 2) upstream train and one additional (Phase 2) downstream train. The project plan was to co-locate the Phase 1 and Phase 2 upstream areas on one side of the building, so that all the live processes were together.

In order to undertake the required works, the shutdown period was set at two weeks. This was one of the main challenges of the project. The narrow shutdown window was required to accommodate CRL’s manufacturing commitments.

The Solution

At the outset, it was found that record information was limited and, additionally, a complete survey was not feasible whilst the sterile area was in production. In order to complete the preliminary design, agreed and considered assumptions were used.

During the site survey, value engineering opportunities were identified to reduce the scope of the builder’s work for the planned shutdown. As an example, to relocate equipment in lieu of the installation of a new compressed air supply, saving a significant amount of builders’ work, time and associated cost.

Project scope included remodelling four small rooms into two larger rooms; the combined room was designed to be Grade C, and all other rooms remained at their current Grade levels.

Floors, walls and ceilings were finished with sheet vinyl to match the existing GMP areas.

As part of the project, new services were introduced in various key locations to serve new and relocated equipment use as part of the process stream.

Through strategic project planning broken down as daily and hourly elements, the project was completed on time and within the tight shutdown duration to meet the manufacturing commitments and quality aspirations.

“Austin were very client focused and determined in driving the project to success. They delivered the project on time and on budget. I felt that Austin were a good choice for our project.”
Nicholas Leonard – Associate Director Global Category Procurement, Charles River Laboratories

“Austin’s design was good considering limited information provided and lack of access to hidden services. Their Construction Project Management was excellent, very helpful and accommodating.”
Keith Miller – Project Manager, CBRE