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GlaxoSmithKline Attachment Inhibitor

Location

Parma, Italy

Programme

2018 - 2019

Sectors

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Story

Fostemsavir is a new life-saving drug used to treat people with HIV who have limited or no other treatment options available. In order to maintain supply while the drug was in development and clinical trials, GSK had to build and commission a brand new facility in a shorter timeframe than had ever been achieved before. Through innovation, commitment and the application of technology, we were able to make that happen.

Our approach was to invest an exceptional amount of focus – both human and technical – into the initial planning stage. We stripped the project back to its most basic component parts, and worked forward from there. Developing and rigorously testing every aspect of a complete end-to-end project plan meant the finished building would go on to be delivered on budget, on schedule and in record time, allowing GSK to maintain production.

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Focusing on the process, not the building

The desired outcome of this project was not a building. It was the successful production of Fostemsavir.

Our approach – the approach which underpins all our projects, including many others with GSK – is to understand the desired outcome, and work back from there to the ideal solution. By modelling and interrogating every aspect of the solution we come to understand exactly what the critical path is, where the dependencies and weaknesses are, and find opportunities for improvements and efficiencies. This requires open minds and a readiness to change from previously accepted practice when the data shows an alternative approach will add value.

The facility was to be built on a 10,000ft2 site in Parma, Italy, which we worked with GSK and their partner, ViiV Healthcare, to identify and assess.

We brought together and led a focused multi-disciplinary team, made up of people with a wide range of perspectives on the project: our local design partners, contractors, engineers, suppliers, and many from GSK itself.

We made sure that everyone understood the importance of the project and felt that they had a personal responsibility to ensure its success. Individuals were involved from start to finish to ensure engagement, and continuity of knowledge. We worked together, in the same physical location.

In order to build understanding of this highly complex manufacturing process, we developed a conceptual model of the project, which is a powerful tool that helps people visualise the design and specify requirements. We held workshops with key stakeholders to evaluate different layout, facility and manufacturing options. We developed strategies that we were confident could be delivered locally in Italy.

The question we kept coming back to was where and how we could save time to get to delivery most quickly. Every aspect of the process was questioned, and nothing taken for granted.

We made extensive use of Building Information Modelling (BIM) and 3D visualisation from the very earliest stages. We used modular design principles for both equipment and layout, to maximise adaptability and flexibility of the finished facility.

We challenged accepted practice in order to drive efficiency. For example, agreeing overlapping design, procurement and construction phases, rather than follow a traditional linear sequence, allowing us to prioritise elements according to variables such as complexity and lead times for equipment ordering and delivery.

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Driving efficiency in the construction phase

The result of all this front-end investment is a project plan that is so complete, so thoroughly explored, challenged and tested, that the execution is subject to very little variation. It can also be completed more quickly.

The forward visibility we had meant we could plan the ordering and installation of equipment using a combination of lead times and construction sequence, allowing us to minimise any dead time during the build.

We added to these advantages by adopting an innovative approach to the construction phasing, dividing the building into three separate construction zones. Each zone was managed independently and split into unit operations, with the overall aim of achieving building waterproofing within four months of starting construction.

We questioned every part of the construction sequence to ensure efficiency and safety, and had dynamic, focused teams working on site, meeting daily and weekly to review progress, and holding four-week look-ahead interactive sessions to keep the process on track.

The Commissioning and Qualification stage – when the facility is put into action and assessed for compliance – presented particular challenges, given the complex requirements of pharmaceutical manufacturing in general, and some unusual difficulties with this product in particular. However, we applied the same core principles of extensive early analysis and planning with a dedicated multi-disciplinary team, to identify the most critical activities and focus decisions and resources.

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Safe, accurate delivery. On time and on budget

The combination of all of the above meant that the project was delivered exactly according to plan in terms of budget, and programme time.

And despite being delivered in record time, the project was benchmarked to ensure that it delivered value for money (it did), and construction completed with no reportable safety incidents.

Rapid delivery did not increase costs or mean any compromise in quality or safety. Instead it brought a raft of benefits.

The Attachment Inhibitor project won ‘Project of the Year’ at the annual GSK internal awards, and ‘Facility of the Year Award’ for Social Impact, from the International Society for Pharmaceutical Engineering (ISPE).


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