Pharmaceutical companies and contract development and manufacturing organisations (CDMOs) that participated and exhibited at this year’s BIO Convention in Philadelphia told us that the main difference over last year’s event was the increased interest in cell and gene therapies.
Over the past year, Fujifilm Diosynth Biotechnologies has made significant investments in the biologics area, such as the 80,000 square-foot manufacturing facility it opened in Texas, US.
In addition, the company has announced the acquisition of a large scale site in Denmark, which is expected to be complete in August 2019, and is also planning to create a continuous bioprocessing manufacturing facility in Billingham, UK.
Fujifilm Diosynth’s president and COO, USA, Martin Meeson (MM), spoke to BioPharma-Reporter (BPR) about the volume demands which, according to him, is the greatest challenge that CDMOs are currently facing on cell and gene therapies development and manufacturing.
BPR: What was new to conversations this year at BIO compared to last year?
MM: It is the interest on cell and gene therapies, which is a continuously emerging area. I think the industry has a buzz about cell and gene therapies, which is great and gets us all very excited. We are looking at the treatments that we are putting out there, and the potential impact that we are having for patients. I am thinking of what we could potentially be involved in and of everything we do to get these drugs closer to the clinic, and also ultimately through commercialisation to a wider population and that is quite exciting. With the late-phase facility we opened in Texas, we now have good manufacturing process (GMP) batches and we are moving into the later phases with some of them. So, we continue to increase our partners to take their products through development, and the level of interest on that is rising.
BPR: What are the challenges in providing services to companies developing cell and gene therapies?
MM: There are some companies with great products and ideas at a very early stage, which are funneling and transitioning from research – and in some cases, almost academia – into the GMP space. Using our knowledge, we have found our ability to help them in that transition because there are differences between research and bringing products and cell lines into GMP. That requires a certain degree of control. We get into these conversations with customers much earlier and help them understand what needs to be done. That has been one of the successes we have had over the last 12 months.
However, the big challenge we are getting into is about the amount of product that people need. The dosing for a liver-related, or even a whole body-related disorder, is quite significant. There are already various studies going on to try and work that out. So, meeting volume demand will certainly be a key part of what we are required to do. We can't make enough product from adherent cell culture, so we have to get into suspension. We have definitely been working to make sure that we can support our customers in that space, as they sometimes come up with some big numbers – but we are looking forward to further helping them. The facility in Texas is well set up and easily expandable to support some of those needs.
BPR: How do you see the cell and gene therapy market developing over the next five years?
MM: I think all indications, particularly based on what people are paying for things, suggest the industry will really take off. There is a serious disproportion between the number of people that have actually been treated compared to the current level of investment in this area. However, people are seeing the potential, when seeing these almost curative treatments happening.
We are almost where we were with monoclonal antibodies (mAbs), 10 years ago – so, I think people are jumping a little bit quicker [into the market] because they can see how it will develop. We are certainly offering a CDMO service much earlier than we would have with the mAbs business.
BPR: What are the clients looking for in the CDMO business today?
MM: I believe our clients choose Fujifilm because they find two things in us, and then they like a third thing. First of all, they know that we have strong scientific knowledge and a strong understanding of what it takes to develop and prepare a drug for production and commercialisation. They are getting good value for their work and good advice on what they need to do. Then, they come to us because we have the facilities. There is a limit on the available facilities, and that is across many aspects, not only cell and gene therapies.
And the third thing is that we try to actually partner with the people that come along with us, including the customers. Sometimes that involves some good conversations, as we try and get our viewpoint across and they get theirs. Really looking to partner is the thing that people want. It is the reason they choose us, and they stay with us, as they do not get it everywhere in the world. We strongly focus on making sure that we understand what they want, and we partner to deliver it. It is a two-way thing, and people we have worked with for several years are still coming back to us, bringing more projects, because of the relationships built.
So, it's nothing without the science, knowledge and capability, but I think being a partner is the third part of what we do, which just makes working with Fujifilm Diosynth such fun.
BPR: What opportunities do you see in other areas?
MM: We continue to invest in traditional services and there has been a number of microbial products coming through at the moment. We have also had a lot of regulatory experience, inspections and commercialisation of projects over the last couple of years. Therefore, people are really starting to see us as the people they can trust to get their molecule commercialised, through inspection and into the market. The number of late-phase products coming through has increased. We are also expanding the facility in North Carolina, in order to handle the volume, both on microbial and cell culture site. Our site in Denmark is also expanding in scale and will now be operating at 50,000 leader scale for antibodies as well, filling out and completing our total offering. Our investments last year have been very successful in formulation and helping us to understand the molecules coming in and to support our clients.
Martin Meeson is the president and COO of Fujifilm Diosynth Biotechnologies. Before joining Fujifilm Diosynth, he was finance director at Oxford Chemicals, resonsible for all aspects of finance, IT, and purchasing. Meeson has also held leadership positions at Hibernia Foods, ICI/Dupont and KPMG.
