The Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Office is publishing a series of case studies, showcasing how they have helped companies to move forward with innovative health plans by providing regulatory advice early on in the process. Working with the Medicines Manufacturing Industry Partnership (MMIP) and the BIA’s Manufacturing Advisory Committee (MAC), the most recent case study featured FUJIFILM Diosynth Biotechnologies. Here, Dr Stephen Taylor, Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies, discusses the evolution of medicines manufacturing and the importance of the MHRA in ensuring more of tomorrow’s medicines are made in the UK.
The world of drug manufacturing has changed massively since I joined the game in the 1980’s. Then it was all about dedicated single-product facilities, pharma doing most of the higher value manufacturing work with little outsourcing and of course it was a small-molecule dominated market. “Biologics were just going to be a transient blip” as one pharma R&D director said to this young impressionable scientist.
Well here we are in 2015 and the sector has changed, albeit at the pace of a turning oil tanker when compared to IT, and biologics now represent the majority of the top ten selling drugs – including first place. The global pipeline of future biologic medicines is well over 1000 and we have a thriving outsourcing sector, with some biologic CDMOs (contract development and manufacturing organisations – I hate it when the ‘D’ isn’t used!) knowing more about biologics processes and manufacturing than many pharma companies do. Biologics won’t replace small molecules and no more will cell therapy replace biologics in the next decade, but the healthy 50/50 balance we are moving towards, with more hybrid products (so a win-win for both bio and chemistry communities), feels like a sustainable projection to me.
And what happened to dedicated single product facilities? Today our focus is more about multi-product operations with emphasis on campaigns and fast change-over between products. Of course there will continue to be future Humira’s which can command their own steel edifices, but my crystal ball says the impact of personalisation and technological advances increasing process productivity, will inexorably lead us down the path towards more flexible manufacturing of small and medium volume biologics and creating facilities to make multiple different biologic products, but not actually knowing what they will be when designing. It’s not surprising to me that ‘single use’ and disposables technologies are going viral in support of this drive.
That’s why it was so important to us at Fujifilm, when expanding our mammalian cell culture cGMP capacity, that we were able to have a great dialogue with the Medicines and Healthcare products Regulatory Agency (MHRA) and ensure that what we built could provide for patient safety, manufacturing efficiency, adoption of new technologies and be able to make the 10 or so different, but still unknown, biologic APIs each year for our customers. With their advice we were able to create an operation that should stand the test of time.
Having an informed and accessible regulator is surely a jewel in the crown of the UK, and the Medicines Manufacturing Industry Partnership (MMIP) rightly has this centre stage. In MMIP we want to see more medicines manufacturing being done in the UK and we hope that the MHRA’s Innovation Office case studies, like the one citing the Fujifilm experience, can help with educating our market. The UK really is a great place for such work.
Fujifilm’s role of course is another of those somewhat unrecognised changes of the past 20 years. I believe that more biologics are now being made in ‘contract’ facilities than in those of pharma – both clinical and commercial. My own estimate is that the combined pipeline of clinical development biologics being made by Fujifilm and Lonza (the two largest UK based biologics CDMOs) in Billingham and Slough for our respective customers, is far larger than the UK pharma biologics pipeline.
We all want more of tomorrow’s medicines to be made here in the UK, so finding ways to persuade companies like Fujifilm and Lonza and our customers to retain their manufacturing in the UK as that pipeline transitions to commercial approved new drugs, is the great route and ought to be a priority.