Alwyn Jones, Siemens Digital Industries Head of Pharmaceutical and Life Sciences UK & Ireland
Ahead of Siemens’ Digital Talks conference earlier this year, I took the opportunity to interview two senior executives from FUJIFILM Diosynth Biothechnologies, one of the world’s leading providers of contract process development and manufacturing services for the biopharmaceutical industry.
As a CDMO specialising in the delivery of recombinant proteins, viral vaccines and gene therapies, they combine technical leadership in cell culture, microbial fermentation and viral vectors with world-class GMP manufacturing facilities.
With over 15 years of cutting-edge experience, and an outstanding track record of delivery, initially our conversation was focused on where FUJIFILM were on the digitalisation journey today. They were very honest in their response, describing how much of their R&D and manufacturing processes were still generally “islands of excellence, automation and data management”, and that they were working hard to bring all of these together.
This move towards a more connected and optimised way of working was seen as being vital as the company moved from ‘Big Pharma’ to ‘Smart Pharma’, and they explained how customers within key sectors such as clinical trials now demanded smaller, bespoke batches quicker than ever before.
Agility, speed and flexibility was also required to meet the increasing demand for more personalised medicines, with very targeted commercial products being developed for smaller and smaller groups of patients globally.
Drilling down further into how this more responsive and efficient way of working can be achieved within a pharma setting, FUJIFILM described the challenge for them over the coming years is shifting its emphasis from the performance of highly automated equipment into the active management of the performance data that comes out of the whole production line.
They described how kit which continues to “spit out information into a spreadsheet or into a database” is being calibrated to bring all the data together, and that the performance from their process development laboratories - and details of what’s happening in our GMP manufacturing being combined - is going to give them the opportunity to speed up their processes further and produce even higher quality medicines.
And while it was agreed that increased data gathering and data analysis was at the very heart of this move towards smarter pharma manufacturing, and that the technologies required to do this were already in the marketplace, FUJIFILM also said an area which could potentially be a barrier to rapid adoption was the appetite for change within the workforce.
When I pressed them further on this, they said that while colleagues had expertise, knowledge and an understanding of value of data, and could see the vital role they had to play in the wider production process, that trying to get that link together across the full businesses was challenging.
They went on to add that despite having a significant lean programme in place, which looked at getting streamlined workflows through their business, the crux of the matter was about making it personal to their people.
This included how to better communicate the benefits of more interconnected practices; highlighting how it could help their colleagues, customers and future patients by ultimately by doing something different with the information they have to hand.
On that point they said: “The people who are actually doing the experiments in the labs, who are doing the quality stability work, that are manufacturing GMP batches, they have a large voice to play because a lot of the issues that they see, the solutions and the revolution of the digital world will help make it more efficient.”
FUJIFILM also explained how this embracing of new ways of working, driven by Industry 4.0 technologies, was also impacting on their supply chain and end user customers. Here they described how some of their bigger customers were very advanced in their digital journeys and were now demanding data in certain formats and certain structures from their suppliers.
However, FUJUFILM also said that one the real challenges was that the digitalisation of the supply chain wasn’t harmonised, meaning they had to deal with different demands and unique issues with different customers.
At the other end of the spectrum for example, working with smaller biotech companies, FUJIFILM said there was much more fragmentation, and as a result were trying to develop a system that was able to flexibly respond to those who had very aligned needs to their business and simultaneously work efficiently with those who weren’t.
What I took away from this fascinating discussion was the fact that even a highly advanced, world-leading and innovation-led pharma business like FUJIFILM Diosynth Biothechnologies is wrestling with the adoption of digitalised processes with regards to its staff, customers and the wider supply chain. This is also why, as manufacturers ourselves, Siemens believes that the transformational Industry 4.0 journey is one that we all need to take together.
You can watch an edited version of my interview with FUJIFIM at www.tinyurl.com/siemensfuji