Can Single-Use Technology Create A Paradigm Shift In The Pharmaceutical Industry?
At Interphex 2014, Todd and Todd Interview Ian Sellick, Director of Marketing for Pall Life Sciences, to discuss the opportunities and the future of single-use technology. Ian talks about how with single-use technology you can actually design something and actually build it very quickly, and if it happens not to work exactly how you thought it was going to, you can change it very quickly as well. With this train of thought, it enables more experimentation, driving a faster pace with new treatments. Nowadays we have tools such as a configurator program that’s a computer-based system which actually helps the user to actually design very quickly the single-use systems and integrate the technologies together. That generates designs that then can go directly to the manufactured. It can take days instead of months to actually come up with a system and then produce it relatively rapidly.
Todd S: Good morning. This is Todd and Todd live from New York. Life Science Connect Radio on location direct from INTERPHEX Day Three. Todd, we have an exciting guest up next. Guest, after guest, after guest is blowing me away.
Todd Y: The education of Todd and Todd continues.
Todd S: Continues. I suspect with our next guest it will continue to continue. Say hello to Ian Sellick. He’s the Director of Marketing with Pall Life Sciences. Ian, welcome to the show.
Ian: Yes, welcome Todd and Todd, or Todd squared I guess we should call you.
Todd Y: There you go.
Todd S: We’ll go with any options.
Todd Y: It’s going to be one of those interviews, Todd.
Todd S: It’s going to be one of those. Ian, gosh, we have an interesting conversation to have here, but before we do that take a quick second to tell us a little bit about you and your background.
Ian: Right, well I’m Ian Sellick. I’m the Director of Marketing for Pall Life Sciences. I’ve been with the company for 20 years now. I actually started off graduating in biological sciences and did post-graduate research, so I’ve pretty much been involved in this general type of area all my life.
Todd S: All your career, outstanding. Go 10,000 feet up with Pall Life Sciences. What do you do? How do you serve your market?
Ian: Pall Life Sciences is an established company. Pall Corporation was founded in 1946, so we’ve been in the area for a good, long time. The life sciences part of the business is an increasingly broad range provider of goods and services all about taking the pharmaceutical industry’s raw materials and turning them into life-saving drugs. We truly do that on an end-to-end basis.
Todd Y: Single-use technology, Ian, something that’s popping up over, and over, and over. It has for a couple of years now. What’s Pall’s vision for single-use technology?
Ian: We’ve actually been involved in single-use really for a very long time, because we have the industry-leading filter technologies. That’s where Pall started off. Really for the last 20 years that part of the process has actually been single-use.
What we have tried to do is to extend the breadth of that, and continue to do that, and to use single-use technology as a way of advancing the industry in the way of making things possible in an affordable way, which may not have been possible before, for example.
Because single-use technology requires relatively less capsule expenditure, it means that companies can maybe experiment with new technologies which may have been too expensive to build a traditional pharmaceutical plant for. Also, it allows the pharmaceutical industry to produce locally. You can just take the same single-use equipment, it’s very simple, and put it down somewhere else in the globe.
But I think one of the things which really would be a real benefit of single-use technology is to take the industry away from just converting a traditional stainless steel process into single-use, and to think outside the box and say, “Do we actually need to do things this way? Can single-use technology actually enable a completely different way of doing things, a paradigm shift in the industry?”
Todd Y: I just want to follow up on something you said, I had never thought of it before. You talked about the lower capital costs involved with the single-use technology.
Then you also said it enables more experimentation. It strikes me that that might drive a faster pace in coming out with new treatments, just because I can fail more often and more quickly, and find the right thing sooner. Is that a sensible train of thought?
Ian: Yes, it is, because setting up single-use systems is a very short-term process. If you’re building a traditional plant, then you have a very long engineering and architectural phase. Whereas with the single-use technologies you can actually design something and actually build it very quickly. And if it happens not to work exactly how you thought it was going to, then you can change it very quickly as well.
Nowadays we have tools such as a configurator program that’s a computer-based system which actually helps the user to actually design very quickly the single-use systems and integrate the technologies together. That generates designs that then can go directly to the manufactured. It can take days instead of months to actually come up with a system and then produce it relatively rapidly.
Todd S: Boy, Todd, that’s interesting. Ian, at no surprise to you we’ve had a lot of conversations around single-use at this show. But Todd, the perspective from a lot of our guests so far has been some new thinking.
Todd Y: Yes.
Todd S: And it sounds like Pall has been a very critical innovator there. Ian, talk to me about sterile connector and disconnector technology. What’s the value to the user there?
Ian: The ability to actually join a lot of these single-use items together in a sterile way is paramount to actually operating single use. You still have a lot of steps in the process, but what you don’t want is this huge octopus of tubing, bio-containers, and other pieces all as one part. You break it into manageable chunks, and then join it together.
An important fact, Pall came out with the industry’s first sterile connectors, and it was actually 13 years ago. That actually, we believe, was the single technology that actually enabled the whole single-use revolution, was a way of actually joining things together.
Obviously a lot of people have competing versions of that now, but it’s flattering to be in that position. Nowadays we have disconnectors as well, because after you’ve finished using a particular piece you need to be able to take it apart again and still maintain the sterility of the system.
The latest thing is with single-use actually going into larger and larger volumes is actually having very large scale connectors as well. Nowadays we go up to an inch and a half flange connections in through connectors, which to you radio guys may not mean much, it still sounds quite small. But for the industry actually it’s big.
Todd S: Oh, no, I appreciate that. Yes.
Ian: Yes, yes.
Todd Y: Are extractables and leachables still something that’s pretty darned important, getting talked about a lot?
Ian: Yes, absolutely, because you’re now using a lot more plastics and a lot of different plastics actually in contact with the fluids, so you really have to understand what they contribute to the process stream. The industry still is coming to grips with standardizing the testing and how those should be evaluated.
But again, we’ve been making plastic devices for the industry for a great many years, so consequently we were in a very good early position on that and some of the guidelines from industry organizations such as the Bio-Process Systems Alliance. They actually encompass a lot of the extractables and leachables work that we had historically done as leaders in that field.
Todd S: Alright, bioreactors and mixers, talk about some of those applications.
Ian: Yes, to start your biotech process you have to grow cells. We have a whole range of bioreactors now. We may have come to that a little bit later than some other people, but it has allowed us to step back and see what was genuinely needed. What we’re doing is to provide a range of bioreactors which actually cover all of the bases in the industry.
We have bioreactors for suspension cell cultures, for recombinant protein production, for example. We have bioreactors which are more suited to vaccine producers, and we have a dedicated range of bioreactors for the newly developing area of cellular therapy.
There are a lot of people looking at cellular therapies, but a very few people have actually dedicated technologies and are investing in the resources for that part of the industry. We actually have some very interesting technology in that area.
Todd Y: Different kind of question. No small amount of time and treasure are required to exhibit here at INTERPHEX, especially over at Booth 3021, some place everybody wants to swing by for Pall Life Sciences. Talk about why you’re here. Why is the investment worthwhile?
Ian: Well, it’s even better than that because we actually have 3341 as well.
Todd Y: Is that so?
Ian: So yes, we have a very, very diverse portfolio of products. I mentioned that we go all the way from taking the raw materials or helping people to grow it, all the way through to packaging. We even go so far as to produce ultra-clean packaging for final products and medical devices.
We do (0:09:20.1 unclear)-free vials. We do systems for (0:09:23.4 unclear) filling, as well as the things that maybe people traditionally have associated with Pall starting off as a filter company. The consequences of having such a broad portfolio is you really need to be in a venue where you get a broad spectrum of people from across the industry coming in, and this is a good venue to do that.
Todd S: Alright. Ian, I hate to say it, but we are about out of time. Before we let you go, how can people get in touch with you and learn more about Pall Life Sciences?
Ian: Well the website of course is pall.com. If you want to get directly to the pharmaceutical industry part, it’s /biopharm. Just remember either biopharm or email@example.com. Your email will find its way to me in a central messaging system, and I actually read every one that comes in from around the world.
Todd S: I love that.
Ian: I enjoy doing that.
Todd S: Alright. Ian Sellick, Director of Marketing with Pall Life Sciences. Ian, it was a real pleasure. Thank you for stopping by and for all your great work.
Ian: Yes, thank you Todd squared.
Todd Y: Alright, thank you.
Todd S: Our pleasure. Alright, well that wraps this broadcast. On behalf of our guest Ian Sellick, my co-host Todd Youngblood, I’m Todd Schnick. Life Science Connect Radio’s live coverage from INTERPHEX will be right back.