A new facility that ensures the continued supply of a critical cancer medicine forms the basis of the first case study released from the Innovation Office at the Medicines and Healthcare products Regulatory Agency (MHRA).
The building features a unique sterile manufacturing process that can help to treat patients with prostate and breast cancer.
AstraZeneca accessed guidance and advice from MHRA to help it successfully navigate regulatory and scientific requirements in the development of the unit in Macclesfield. This helped the team to develop the site quickly, cost effectively and ensured the production of vital cancer medicine in the UK.
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
Through offering scientific and regulatory advice to companies in the early stages of medical developments, the Innovation Office is hoping to support a number of emerging new technologies that could change the way in which medicines are developed.
MHRA director of inspection, enforcement and standards division, Gerald Heddell, 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.”
John Parker, UK quality director at AstraZeneca, added: “MHRA was very supportive and collaborative in its 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.”
The case study is the first in a series to be released by the MHRA that were developed with the Medicines Manufacturing Industry Partnership (MMIP). MMIP, which was launched by the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) earlier this year, brings the UK’s medicines manufacturing industry together to create an attractive and innovation-rich environment to drive UK competitiveness and build international recognition in medicines manufacturing.
Case study
The issue
In 2013 AstraZeneca was considering options, including 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 the MHRA helped
After being contacted by AstraZeneca and listening to the key issues, the MHRA arranged for a senior expert in aseptic manufacturing to visit the proposed site and followed this up with subsequent visits and meetings at key stages of the project.
The MHRA helped in a number of key 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). This 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 mock-up 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 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
The outcome
AstraZeneca’s proposal to build its new £120m facility at its site in Macclesfield was approved by the board in November 2013. Within 12 months of approval, AstraZeneca constructed a 5300sq m 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.
