Moderna Innovation and Technology Centre, Oxfordshire

This facility has capacity to produce up to 250 million vaccines per year

A sustained acceleration programme to deliver an offsite CQV in a pandemic timeline

Client Moderna
Duration15 months
Value£75M

Challenge

At Moderna, the client set the challenge of saving 17 weeks on the overall construction, commissioning, qualification and validation (CQV) programmes. By establishing an on-site equipment testing facility, the team were able to provide a 10-week saving against the critical path. This included the fit out of a Drug Substance Facility, including associated manufacturing, cleaning, administration/office, warehouse, laboratory and hydronic/hygienic utility areas. This facility manages the process from raw materials to final product testing and shipping.

Commissioning, Qualification and Validation (CQV)

The facility allowed the CQV team to start pre-commissioning, Site Acceptance Testing (SAT), calibrations, temperature mapping and other qualification activities for key mobile process equipment prior to full fitout of their final location. The facility needed to have cleanroom environments, the process needed to provide performance and repeatability and the process-related equipment needed to be compliant with URS (User Requirements Specification). 

Moderna lab

Innovation

Using Facilities Qualified Process system in an OOO location, then migrating it back to its permanent servers without loss of qualification. Multiple bays allowed simultaneous testing, including connections for IT, automation, chilled water, compressed air.

Direct connection to permanent building to transport equipment. Clean, temperature-controlled environment and no impact on construction or logistics, but clean, quiet environment to execute CQV.