Industry Perceptions Of Integrated Continuous Biopharma Manufacturing

On day three of Interphex, Todd and Todd interviewed John Bonham-Carter, VP of business development with Refine Technology. Bonham-Carter discusses some of the biggest hurdles that exist in the integrated continuous bio-pharma manufacturing realm, touching on industry perception and the hesitation to unite the upstream and downstream processes. Bonham-Carter also believes that single-use is now an industry norm and that the industry is on its way to accepting this, however more work needs to be done fix some of the problems with the technology.   

 

Interview Transcription:

Todd S:            Good morning, this is Todd and Todd live in New York, Life Science Connect Radio on location direct from INTERPHEX day three. Todd, we have an exciting guest up next. But gosh, never ceases to amaze me how much amazing information we learn and the amazing people delivering it.

Todd Y:            Things start to spill out of the top end of your brain because you've got more stuff coming.

Todd S:            Oh yeah.

Todd Y:            I can't hold it all in there.

Todd S:            I know.

Todd Y:            They've got to put me in a smaller group I think.

Todd S:            I'm so excited that we are providing all this great stuff to our audience. So, next up is a gentleman named John Bonham-Carter. He is the vice president business development with Refine Technology. John, welcome to the show.

John:                Thanks very much. Great to be here.

Todd S:            Before we get into our conversation, John, take a few seconds; tell us a little bit about you and your background.

John:                I've been in the industry about 15 years now; it's not a lot, but actually, if you go back probably 1960s, my grandmother got our family into this business with [00:00:53] [inaudible] back in the 60s for [00:00:55] [inaudible] engineering and my father took over, and I tried to avoid, but I got dragged in.

                        Just when I thought I was out, they keep pulling me back in. Actually it's something useful, but I try not to do something, well, hopefully, very useful.

Todd S:            That's fun to be, saving lives, you know, whatever.

Todd Y:            How can you say no to your grandmother, it's not possible.

John:                She was a strong woman.

Todd S:            Yeah the benefit of mankind, what are you going to do? You're going to [00:01:20] [cross talk]

John:                That's right.

Todd S:            Well, define technology. Tell us all about it: what do you do, how do you serve your market?

John:                So, Refine is a company about 10 years old— although already we've seen success in the last four to five years. We make a product called the HS System. And that has now become the leading industry product for sale retention, and that is driven primarily by similar companies who want to be reducing cost of goods in manufacturing biological drugs.

                        And it's been a long journey, and now we are experiencing the growth that we've been working for for four to five years. So it's an exciting time.

Todd S:            Integrated continuous biopharma manufacturing, I mean, it's hard to say it's a whole lot harder to do. What are some of the biggest hurdles?

John:                So, I would say the biggest hurdles are perception, actually. So upstream and downstream are the two kind of parts to the process. We work in upstream, and in fact, our product is not that novel, it's not revolutionary, evolutionary, and people are already using it in commercial manufacture.

                        And so, it's kind of accepted, and so the downstream, there are products that exist less obviously dominated by one or two. But the putting together of these, there seems to be some kind of barrier in the industry. No one has really been doing this before. And this is worth changing.

                        So it's primarily perception that's not been possible or the games weren't there. Maybe people thought the equipment wasn't quite right. But my personal feeling is that you just didn't need to do it.

                        The company when they made drugs, the cost of goods was not important. They could get a profitable drug out and then -- so they didn't need to optimize the process, and that's now changing.

Todd S:            Alright. How are we going to do this? How are we going to make what seems impossible possible? How is Refine going to contribute to that?

John:                Well, we are definitely the small player in this. It's going to be led by leading companies such as Genzyme, Merck, other people who see this is a requirement for the next generation of processing.

                        So they've got teams now that work, and the key thing is to integrate these upstream and downstream teams together and make sure that you've got an integrated approach to the process.

                        And this is going to drive lower cost of goods. Drugs are expensive in the market, and that's got to change, and these big biosimilar drugs of the billion dollar-plus market, these biosimilars coming in, mean that more people are going to share that, the cost of manufacture is going to become a key issue.

                        And so these large companies are going to drive really, companies like us to provide the right solution to them, to make a lower-cost drug.

Todd S:            Talk a little bit about the technologies that are being developed and deployed to get the continuous manufacturing in place.

John:                Right, so I think the technology to a large extent already exists. We for example have a technology based on hollow fibers which is very nice to touch the bio reactor and, with running it, you get very high solvents 50 to 100 million cells which is five to ten times more than the industry standards today.

                        So that drives productivity. And the nice thing about something that we produce is, it produces like a filtered strain. So you go directly to the next step of capture.

                        Previously you had whole steps of tanks, you had centrifuges, you had dead filters, all of which are known technologies which will work but add steps, add complexities, add time to develop. So the removal of that is kind of a key advantage now for the industry.

                        And then going to that capture step, there are quite a few technologies from Novasep and Tarpon that have a kind of continuous element to them, and if you're going to marry these two things together, and those new companies are pushing the boundaries, really, and saying that this is now possible, this is not, again, this is not novel, this is off the shelf, and it's reassuring to the industry that what is the current technology is safe.

                        And that conservative view of the industries is driven by the regulator. You don't want to be taking too many risks with drugs that are going to be injected in humans. You've got to be [inaudible] [00:05:25] to make sure that risk is understood.

                        So having technologies which are super reliable is really key. And this technology exists, but they've got to be understood how to be used in the individual company.

Todd S:            Right. Well let's talk about single-use systems. What role do they play on all of these?

John:                Well single-use, you go back about 10 years, very nice man called Vijay who invented the wave, the first [inaudible] [00:05:46] director, I mean 12 years go.

                        That was a defining moment because the industry said at that point, "This is a lot of rubbish. It's a plastic bag; we are never going to do it. We've got the big stainless steel tanks of 10, 20,000 liters; I'm not going to use the plastic bag to grow cells." And the industry is radically transformed.

                        So that is now the standard. Maybe not his rocking technology but the whole industry, if you look around at its effects today, everybody has got something single, including us. We've got a thing he's launching this year.

                        And the drivers for that, of course, are that it's lower capital expenditure, which has strike the bottom line. It's fast start-up so you can delay decisions before you have to commit a large amount of capital to a project. And from a continuous view point, it's complementary.

                        The one thing that continuous processing isn't helping is the sea to manufacture a certain amount of drugs is reduced. For any period of time you can get the drug out quick using continuous technology. And so I think this complements that.

                        The ability to delay that decision for manufacturing is taking away a lot of risks in the industry when so many drugs fail; you just don't want to be committing capital before you know you're going to need it.

                        And so yeah, they're complementary and that will drive down that cost of good that we talked about right at the beginning and keep the cost of the development and the cost of manufacturing low.

Todd S:            I'm sorry, two- part question, what's the single biggest thing, be it technology or process that's currently being implemented that's having a major impact, and what's the next one going to be, in your opinion?

John:                Well that's a good question, and it's a little difficult to point out one thing, I would say. I think the biggest thing is not a product, it's an idea. And in fact, five years ago, companies like ours were going nowhere.

                        I was evangelicizing the sales and saying, "Come on guys, you have to do this. Come on girls, this is the way forward. But actually no one was listening and now people are listening, and that is a big change.

                        So that's why compared to practice single-use, people dismissed it all and now it's dominating. And the issue is, is that story going to repeat? That's not clear at all. Companies such as Genyzme, Merck, even people like Amgen and others who are experimenting with this technology or implementing it fully, these people are now realizing this could change the way the industry manufactures biological drugs.

                        And if these problems of how to organize facilities, how to retrofit existing or build new of those, get solved using the technologies that are out there, these can make a dramatic difference and really lower the barriers to entry to a no longer the small group of highly specialized companies that a large amount of capital can do this, it kind of democratizes manufacturing falls on to the drug. And that could transform health care [00:08:40] [inaudible].

Todd S:            I trust that you're a keen observer of the industry, and we are unbelievably, we are past halfway done on a final day of INTERPHEX. Right, I want to know what Mr. Bonham-Carter's key take aways from INTERPHEX are going to be.

John:                Wow! That's interesting. I will grant into the fact that it's a big show. It's got pharmaceutical equipment, it's got everything from packaging to the area that I'm in, which is the biological area, the biological manufacturing area.

                        INTERPHEX has been a great show for people who want to see new technology, what's going on, good possibly to network; there has been some good talks this year. There is [00:09:16] [inaudible] which I've contributed to and that exchange of information has been great.

                        But I think my big take away is, one, that single use is now an industry norm and it is completely accepted that's the way the industry will go. Nonetheless there are problems with that technology.

                        This is not the be all end all, it will not be for 100% of the product, but everyone knows for the vast majority that that's going to happen. And the small take away is that from a few years ago, continuous processing was not even mentioned at the show.

                        And now there is a whole day yesterday of talks and all sorts of people from [00:09:55] [inaudible] to ourselves saying, this is what we are working in this phase. This is how we think it will develop.

                        So those are, one establishment of the technology and another of an industry, really, and the second part being the realization there is a new wave, a new attitude in industry, which could be just [00:10:15] [inaudible] transformative.

Todd S:            One more question also looking ahead, what's the single biggest challenge that you say that you personally want to go attack?

John:                Wow! I think you've got to hit the big people. It's when people like Genentech, Roche, Amgen, when they fully commit to a technology like ours, which our company is driving forwards and are still trying to make people see that these benefits are available to everyone, when they commit, that's an exciting time.

                        And Amgen building a facility in Singapore is really that first step along that road. So we are kind of excited about where we are and we are going to do more of the same, and hopefully people follow the lead of these company like Amgen and Genentec [00:10:56] [inaudible].

Todd S:            All right John, I hate to say it, we are out of time. Before we let you go, how can people get in touch with you and learn more about Refine Technology?

John:                Well, in our company they can go to refinetech.com. If they're interested in continuing with bio processing, they can go to the website continuous-bioprocessing.com, depending on what interests them, explore the website.

Todd S:            Great, John Bonham-Carter, vice president business development with Refine Technology. John, it was a real pleasure. Thanks for stopping by and joining us.

John:                Thanks for your time.

Todd Y:            Todd and Todd, it's our pleasure.

Todd S:            All right. That wraps this broadcast. On behalf of our guest, John Bonham-Carter, my co-host Todd Youngblood, I'm Todd Schnick. Life Science Connect Radio live coverage from INTERPHEX. We will be right back.