We were initially engaged by MedImmune in 2008 to undertake a site master plan of the Speke Site in Liverpool which included a number of options for facility upgrades. In 2010 MedImmune asked us to revisit the original site master plan and produce conceptual options for three scenarios based upon forecast capacity expansion requirements.
Based upon the success of the site master plan, MedImmune engaged us to deliver a concept design and then basic design for a number of options. MedImmune proceeded with the detailed design and construction of the facility in 2010, and engaged us to deliver the detailed design, working in collaboration with a construction management partner to provide engineering support to the project delivery. We were also engaged to deliver the validation of the process, equipment and facilities.
Due to the nature of the raw materials, a number of the equipment suppliers had no previous pharmaceutical experience; we worked closely with these suppliers to ensure that they fully understood the specialist requirements of the regulatory environment of biopharmaceuticals.
As the manufacturing processes being introduced were new and had not been used previously by the client, we worked closely with the client and equipment suppliers to ensure that these processes would be appropriate, robust and effective. In addition, the phasing of the project had to be established in order not to disrupt manufacturing campaigns and to fit with planned manufacturing shut downs. The project was successfully completed in 2012.