The Emergence Of The "Flex Factory"Source: Finesse Solutions, LLC
Guise discusses some of the challenges the industry is facing, in particular the rising need for quick, “nimble”, and “flexible” clinical and scale-up processes. Guise says that the industry is growing increasingly interested in “flex factories,” or a complete package solution to a disposable facility, and that this Flex Factory concept will be the next biggest thing to affect the industry.
Todd Y: Your brain getting full yet?
Todd S: It's darn near full.
Todd Y: I've got maybe a quart left to go.
Todd S: Well, we have a great guest up. Say hello to Jack Giese. He's the director of commissioning and validations at Finesse Solutions. Jack, welcome to the show.
Jack: Thank you very much for having me.
Todd S: Our pleasure, Jack. Thanks for stopping by and joining us. Before we get into a conversation around Finesse, take a few quick seconds and tell us a little bit about you and your background.
Jack: I've been in the biotech industry now for approximately thirty years, mostly working in the manufacturing, pharmaceutical medicines, design, and construction of pharmaceutical facilities.
Todd S: Give us the 10,000-foot view of Finesse. What do you guys do? How do you serve your market?
Jack: Our main focus is disposable transmitters and measuring devices, as well as our automation control platform. We are able to integrate with most customers' pharmaceutical disposable equipment and integrate that into the working system in their facility.
Todd Y: We've talked about single-use. I hear something like disposable transmitters. Are we getting to the point where everything's going to be single-use in this industry?
Jack: We're trying, anything to get away from clean and steaming validation, to save that cost association. That's what we're looking for now, in this industry.
Todd S: What's driving all that?
Jack: It's just a lot of testing and the costs associated with doing that cleaning and steaming validation testing. It can run up to ten to twenty percent of your project costs. By bringing that equation back down, you can actually invest that back into better control technology for growing your products.
Todd S: Walk through some of the critical products in your portfolio.
Jack: I would say the one that's our flagship is our optical DO and pH sensors. These actually have a disposable sheet that's in contact with the product, and the sensor itself is removed from the process. It could be gamma radiated with the bag, thrown away at the end of the process, and you still have the major instruments there and reusable for your next batch.
Todd Y: Back up a little bit, and talk about the challenges that the industry's facing.
Jack: I think the need is to be quick and nimble and flexible, because the costs associated with bringing products to the market now are getting so large that you have to be able to make a Phase I, Phase II clinical on a smaller scale, and be able to scale it very quickly, to get to the markets, so you can get that market share.
Todd S: Is it fair to assume that Finesse is equipped to do that nimbleness?
Jack: Yes, we're very small, and we work well with all of our customers. We mostly can integrate five to six different vendors' worth of equipment, so if you're using a disposable bioreactor, it doesn't matter to our control platforms what the vendor type is. We have to, very quickly — within five minutes — be able to switch from one vendor type to another, for the disposable bags.
Todd S: Talk more about the integration and how important that is. I mean, there's so many different moving parts.
Jack: I think what we bring to the market, with our system, since we can standardize this for a control platform, that the validation of the system is very quick and easy. We have our own validation documents and we'll go along with this system, to make a very affordable option for choosing our control systems.
Todd S: How do you simplify tech transfer? Walk us through that.
Jack: With our system, you actually have the ability to load and save programs and your files, all your file data. If you're producing at your clinical facility, an R&D facility in one state, and you need to move it across the ocean to a facility in Europe, you can actually transfer those recipes, load them on to your operating system in a new facility, and you're actually up and running with the same parameters.
It's not a paper tech transfer that makes sure you're entering all those parameters correctly. You can have hundreds and hundreds of different parameters, actually, in the back end of these systems.
Todd S: Jack, you've talked about the speed of getting aligned, up and running. You've talked about cost reductions on a qualitative sense. How much money, and how much time is really involved here? How much are we saving?
Jack: Typically, on a stainless steel facility in the past, where I've worked, it can be anywhere from a five to six year project to go through the design, construction, and start up with those facilities.
With the disposable facilities, we're looking at being able to do that same type of project in probably a 12 to 18 month time period. Just those extra two and a half, three years to get the product first could mean a big difference to a company.
Todd S: Well, you're exhibiting here at Interphex. What are you showcasing? What are your goals and objectives?
Jack: We have several new product lines out here, so we're trying to highlight those, one of our disposable technologies. We now have a disposable three liter vessel. With our optical readers inside of that, it gives you the ability to use it once, dispose of that vessel, and no more costs associated with cleaning, steaming, and autoplating of a glass vessel.
Todd S: What next? Let's look out three years, five years. What kind of technologies do you see becoming important, and how will that impact what you're doing?
Jack: I think what we're driving towards, and what the customers are asking for now, is a complete package solution to a disposable facility. Flex Factory is what it's being called these days. The ability to bring in and integrate all of the upstream and down processing needs, bring them all together under one automation platform, collect that information so you can quickly analyze your data and release your batches.
Todd S: Alright, Todd, we're starting to hear about this Flex Factory a lot more now. Walk me through, Jack, what the value is to the end user, at the end of the line.
Jack: What happens to that, again, being quickly able to get your product back to the market – by having this, the cell culture side, upstream processing side, titers have gone up very quickly, and are able to produce more with less, so smaller vessels, smaller footprints. The downstream is still trying to catch up with that technology. You're still running fairly large on your purification and recovery system. It's trying to minimize the vast sizes on one side, to meet your process on the back end.
Todd Y: Jack, how long do you think it'll be until the Flex Factory is a common thing?
Jack: I would say that's probably one to two years out. That's really getting a lot of cracks in these days.
Todd S: I wouldn't have expected that. That's going to change everything. The conversations we'll have on this show in a year or two's time is going to be dramatic, as a result of that. It's that profound in the industry, right?
Todd Y: You know how long – I've been around manufacturing my whole career. Flex Factory is the term I hear, but in my brain, I'm always saying that it's a disposable factory. That just blows my mind, that we're even talking about it, no less doing it in a year or two.
Todd S: Yes, pretty fascinating. Jack, I hate to say it, but we're about out of time. Before we let you go, how can people get in touch with you and where can they learn more about Finesse Solutions?
Jack: You can come to our website, www.Finesse.com, and you can see all of our new instruments and products available on the market today. Contact information is there for us, also.
Todd S: Alright, Jack Giese, director of commissioning and validations with Finesse Solutions, Jack, it was great to have you. Thanks for stopping by and joining us.
Jack: Thanks a lot, Todd.
Todd S: Alright, that wraps this broadcast; on behalf of our guest, Jack Giese, my co-host, Todd Youngblood, I'm Todd Schnick, Life Science Connect Radio's live coverage at Interphex. We'll be right back.