How Fujifilm became a contract manufacturer
Some might believe Fujifilm and Mitsubishi would make strange bedfellows, but a joint venture between the pair has resulted in the contract development and manufacturing organization Fujifilm Diosynth Biotechnologies. The parent company has said it aims to hit $1 billion in worldwide sales for its bio CDMO division by 2024.
BioPharam Dive sat down with Steve Bagshaw, CEO of the joint venture, to talk about their customer base, the move to gene therapies and how the industry is evolving.
This interview has been edited for clarity and brevity.
BIOPHARMA DIVE: Why Fujifilm?
STEVE BAGSHAW: That might be the first question anyone ever says, "Why Fujifilm?" We've been part of Fujifilm now for seven years and very much part of their healthcare commitment. They wanted to leave the traditional fields of film and document solutions and move into something that would have a longevity — something they could bring that technology into, but wasn't necessarily doing what they used to do.
They're working with us in biotech manufacturing in a way that we have never really got to the levels they've got us to in terms of being able to get manufacturing quality right the first time using some of the technology development that Fuji has in their heads. For us it was an unusual combination because we had the same reaction when they were buying us, "Well, why are you buying?" But it's become more and more obvious as we've been doing it that these guys have a depth in this area that is really helping us.
What do you bring to the table?
BAGSHAW: We're the people who are just basically making sure that there's a whole supply chain of big pharma, medium pharma, biotechs, mobile techs, all wanting to work with us. Then we've created a road map of services that we can provide to the market and in the last seven or eight years we've spent maybe $250 million investing in assets. We're now 1,200 people strong in three locations in Texas, North Carolina, and Billingham in the northeast of England.
In those three locations we offer a service to the market of development, analytical sciences, analytical services formulation and then in certain fields we're also doing drug products manufacture, in terms of making the final dose for the project. But typically we stop at the end of making the drug substance, and then another expertise is to actually put that in the vial or the syringe or whatever the package that they think the market can use.
We have this business really that's a really nice combination. We're a joint venture in Fujifilm and Mitsubishi. We don't publicize too much the Mitsubishi piece. It's an 80/20 [split] but Mitsubishi are long-term trading partners of the world and so we use that expertise in terms of partnership and we use the Fuji expertise in manufacture and technology development. That's where we come from.
The biotech world has changed dramatically in the last five to seven years, particularly on the manufacturing side with the advent of new technologies. How has the company evolved with that?
BAGSHAW: We've really invested heavily in single-use bioreactors and mobile clean rooms. Creating clean room spaces that are very reconfigurable for small quantities and using single-use bioreactors because we find that we spend a lot of time just cleaning your facilities because we're very multi-product. If you have a big quantity of something to make, you've got a choice really whether you would make it yourself or get a CMO to make it.
Typically, we'll have 70 different clients that we're partnering with at any one time all going towards manufacture in our three facilities. We can reconfigure the plan to do any process they want. To us, that's really helping them because not everybody wants the same process.
We're also developing platforms so where there is a platform opportunity we'll do it, but actually our history and where we came from is, "You want this. She wants that. He wants that. They're three different requests we'll make it for you flexibly."
And that's differentiated us actually from the competition, because the competition were very much about going, "It's our way or the highway." We came in and said, "Well, we're the new kids on the block," and we couldn't win by being, "It's our way or the highway." We had to develop flexibility, and that's what we've done and we've made it a strength.
Hence, now we see the good we've done now. We're growing faster than we've ever grown before. We had another record year last year in terms of sales and profit and then continuing to grow like that and Fuji investing in us year on year to do that.
Tell me about your client base. Are they in a particular phase? Of a certain sized company? Certain therapeutic areas?
BAGSHAW: Phase-wise, we've got many preclinical and Phase 1 customers. We're playing in that front end very much. Often we'll make a batch for somebody and we'll never see them again at that company. What we find is the guy or the gal that brought it to us will come with their next company in five years time going, "Hey, I'm back."
It's like old friends coming back bringing their new company to see us because five years ago we did this great project for them, made something, and now they're coming for new technology. People are bringing us microbiome projects or they're bringing us gene therapy projects. Some of them are the same people that brought us cell culture products five, 10, 15 years ago.
We've got three, four or five big pharma collaborations where there's a — I don't know what they'll ask us tomorrow to do, but because we've been willing in the past to listen to them and say, "We've never done that before but we'll do it with you," that's taking us places we've never been. It's great.
Gene therapy is one of these areas where they're going, "We know that if we grow this business, we don't know how to make it. We'll partner with you because you're dealing with all these people, all these small guys. You're gaining a technology sense of what's possible and we want to work with you going forward," and that's fantastic that people are trusting us to be the leaders in gene therapy.
How have you handled some of the hurdles of gene therapy? Transport hurdles, turn around time on things like this, manufacturing consistency with the product?
BAGSHAW: We've had to recruit people who know what they're doing. We brought some great players, but our track record is growing because we brought the same approaches that we have to cell culture and fermentation. We've brought that to the repeatable mentality and to doing process development in our laboratories, in Texas particularly, and using that same methodology to create processes that are repeatable.
We're all wrestling with the same thing, which is how do you do the scale up? How do you do regulatory scale up, because it's quite different biology really, so how do you do that? We're playing in that field, very much partnering and getting involved. We don't have the answers, but we know we've got a track record to help us in that area so that's what we're doing.
There's been a lot of consolidation across your field. How has that impacted you? Is that bringing in more business or creating more competition to get clients?
BAGSHAW: A bit of both actually. Consolidation where it means someone wants to close a site is always a problem. If it's consolidation where they're just changing the name on the front door, not much business comes out of that. What's interesting, I think, is everyone recognizing that you've got to be a long-term player.
I think the whole CDMO industry has gained reputation there actually, and we've all benefited from all playing a longer-term game, because we're all long-term partners now.
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