In 2013 AstraZeneca was considering options, including the location for building a new facility to manufacture an established sterile implant used in the treatment of cancer.
The manufacturing process is unique, technically complex and involves multiple aseptic stages. The new facility would be built alongside existing facilities, creating additional challenges. MHRA was contacted at the conceptual stage of the project to gain clarity on regulatory expectations, particularly in relation to future trends in aseptic manufacturing.
How MHRA helped
After being contacted by AstraZeneca and listening to the key issues, MHRA arranged for a senior expert in aseptic manufacturing to visit the proposedsite. They also followed this up with subsequent visits and meetings at key stages of the project.
John Parker, UK Quality Director of AstraZeneca said:
MHRA was very supportive and collaborative in their approach with us. It was essential that we had a good understanding of the regulatory expectations very early on in the process to understand the impact on design, cost and timelines in proposing the business case for the Macclesfield location. I genuinely believe that having easy access to MHRA in this manner provides a real competitive advantage to UK based companies.
AstraZeneca said that MHRA helped them in a number of ways including:
- visiting the proposed site at the conceptual stage and providing a clear view on what level of barrier technology would be expected (in the context of the unique nature of the manufacturing process), which enabled AstraZeneca to quickly finalise the design of the facility at a very early stage - this helped
a fast engineering definition to be developed leading to board-level sanction for this £120m project in November 2013
- fully appreciating the challenges the project faced through the review of a full-scale mockup and providing well-considered and detailed feedback on specific aspects of process design in a subsequent site visit
- facilitating a detailed review of the proposed validation strategy, employing a number of experts within MHRA leading to prompt feedback - this advice ensured that the overall validation package would meet the regulatory expectations, but also included some creative suggestions on how this could be
achieved more efficiently in terms of time and cost
- providing assurance that the advanced technology being installed in the new facility would not create any concerns, as it would operate in parallel with existing facilities
- offering support and showing interest throughout the process, ensuring the facility was well designed
AstraZeneca’s proposal to build its new £120m facility at their site in Macclesfield was approved by their board in November 2013. Within 12 months of approval, AstraZeneca constructed a 5300m2 facility with 40% fit-out and with the first phase of equipment delivered. This facility is crucial in ensuring the continuity of supply of a critical cancer medicine.
Gerald Heddell, Director of inspection, enforcement and standards division, MHRA, said:
We at MHRA welcome early approaches from companies who need access to expert knowledge, guidance and experience of regulatory processes. As well as being a regulator, we also recognise the importance of supporting companies in their planning processes, in order to ensure positive outcomes for public health.
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