"Podified" Manufacturing Facilities and Risk Mitigation of Aging Pharmaceutical Facilities
Maik Jornitz , Chief Operating Officer, of G-Con Manufacturing, was interviewed at INTERPHEX 2014 to discuss current and new facility designs for the pharmaceutical manufacturing industry. Maik is the co-chair of the PDA task force on aging facilities. Pods can be transported into either new or existing facilities. Pods can then be connected to the existing utilities and the once aging facility is now a modern facility. G-CON’s flexible, modular production units, PODs, are a unique, disruptive technology, which has not been seen within the industry since single-use bags entered the market. PODs will change the production site design of future facilities in the pharmaceutical, but especially biotech and CMO segment.
Todd S: Good afternoon. This is Todd and Todd, live in New York, Life Science Connect Radio on location, direct from Interphex day two. Todd, we have an exciting guest coming up. If this conversation is anything like the pre-show chat, we're in for a good ride.
Todd Y: We veered off left and right a little bit there, in the pre-show chat.
Todd S: We sure did, but boy, looking back upon today, though; it has been an amazing day with some scintillating conversations.
Todd Y: It really has. It's the conversations and the depth of knowledge that our guests have been able to share with us. I think that's why we need to take that little veer left and right, just to have a mental break. But let's get back into it.
Todd S: Well, speaking of our next guest, say hello to Maik Jornitz. He's the chief operating officer at G-CON Manufacturing. Maik, welcome to the show.
Maik: Thank you very much.
Todd S: It's good to have you. Thanks for stopping by and joining us. Maik, before we get into a broader conversation around G-CON, take a few seconds and tell us a little bit about you and your background.
Maik: I'm a bioengineer from Germany, Hamburg, Germany. I moved to the US in 2002. I'm over 30 years in the industry, bioprocess industry. I formerly came from the [INAUDIBLE 00:01:03] engineering side, [INAUDIBLE 00:01:04] equipment side, and now the facility side.
Todd S: Alright, three Germans on the show. That's outstanding. Go up to 10,000 feet and tell us all about G-CON Manufacturing. What do you do and how do you serve your market?
Maik: G-CON Manufacturing is a very young company. It was founded in 2009, comes out of an idea of serving the personalized medicine market with mobile cleanroom systems, autonomous cleanroom systems, which then move from the personalized medicine field right into the bioprocess field, and even the oral solid dosage form. What we see with G-CON, or what we create with G-CON is an equipment which, in the future, will revolutionize the cleaning and facility design system.
Todd Y: What drove demand for this?
Maik: In personalized medicine, it's a patient-by-patient medical therapy. When you actually take patients within patient’s samples, within clean room systems, it's very difficult to sanitize the traditional clean room system. We could cross-contaminate, for example, clean rooms.
It's very difficult to sanitize them. Personalized medicine being, really, the next biotech, the demand for containment of patient samples and also the scalability without requalifications put the pressure on designing new, innovative clean room systems. It's like a clean room bot.
Todd Y: Where would I install this, or is that the right word, even?
Maik: No, that's the right word. What we do is we actually – if you think about it, it's really a box. It's like a walkable isolator. We build it outside, and then we would actually slide it in via [INAUDIBLE 00:02:46], into any kind of facility. It can be a shell building, like this here, like Interphex.
What you do is you put utilities onto the port, like chilled water, electricity, any kind of utilities required to fill the clean room part, and connect the corridor on the other side of the port, and you have an up and running clean room system. It's very, very simple.
Todd S: Maik, walk us through it. What are the advantages to a pharma manufacturer on doing this, versus the traditional way?
Maik: The traditional way, if we really go back and look at the brick and mortar facilities that cost you around $400 to $800 million, it takes four years to build a facility like this and have it up and running, and it's, most of the time, product-dedicated. It means you really put just one product, and then when this product reaches its life cycle, you mothball the facility.
With this unit, you actually lower the capital costs, but the time to run is actually twelve months, twelve to eighteen months instead of four years. You're very, very fast to deploy it. You can deploy these facilities very fast. You can repurpose the clean room ports – we call them ports.
With a repurposing, you can actually get a multi-product life cycle out of the port. Plus, they're very flexible. You can actually connect them together. They slide together, and what we see is they're mobile, so you can slide them across the floor, which means you can pick up these parts.
If you don't like the location where they are, if you need to move out of a location, you cannot dismantle a traditional facility. Well, with a port, you can just discouple the port, move them out of the building, put them on a flatbed truck and ship them wherever you want to have them.
Todd S: They're mobile, you say. Do you use a forklift? How do you move them around? Can Todd and I move them around?
Maik: Yes. You two could actually move them around.
Todd Y: Two old guys like us could move it?
Maik: Yes, except you don't want to be between the port and the wall, because the thing has momentum. They have air bearings underneath them. If you just think about air hockey, it's exactly the same principle, except reversed.
What we do is we actually have air bearings underneath the floor of the port. We put the compressed gas on it, it lifts up, and then we can move these ports around. At booth 2421, you can actually see a video of how our staff is moving ports into a shell building.
Todd Y: What's the life cycle of one of these pods?
Maik: Twenty years. It's welded aluminum, it's very robust, so the construction itself, when you look at the aluminum construction, it's very robust. We believe we get at least twenty years out of it.
Probably what we could do, if we could just resurface the finish on the inside, if there are any damages, you could resurface it easily, way easier than with any kind of dry wall or plastic panel, due to the fact that you've just retouched the epoxy flooring.
Todd S: Let's say I'm a CFO. My question's going to be, “What's the cost impact, versus a traditional clean room?”
Maik: A very good question. What we see very often is that people compare the clean room surface area, or the area, with any traditional clean room. That's actually a mistake. You have to look at the total cost ownership when it comes to pods, because you look into a traditional facility, you have to depreciate a facility as a facility, for example. Pods can be depreciated as equipment. When you look at the -
Todd S: I want to catch that. A pod is considered equipment? You can expense that?
Maik: Yes. The pod itself, also, when you look at the ductwork, for example, it's very complex ductwork. You don't have a super structure on top of your pods. In traditional building, you have to build a superstructure, it takes a lot of engineering hours, and it takes a lot of time to build this.
Nothing like this happens. We'll run the clean room build up parallel to the building build up, and then slide it all together. Again, from a cost perspective, it's not just the cost, but it's also the time to run, which means how fast can you run your product already through the facility? We can run the product through the facility in half the time of a traditional facility.
Todd S: Maik, I'm thinking, as I look ahead, when we interview you at Interphex 2024, we're probably going to be doing it from our mobile studio pod, and there will be probably lots of pods around the chamber. In all seriousness, I'm beginning to think that pharmaceutical manufacturing is going to look very different in twenty years. Where do you see this going?
Maik: I think they actually will look very different in five years.
Todd S: I think you're right.
Maik: I think it's not really 2020 or 2024. Seriously, we will be way, way faster with these, what we call our “podified” facilities. Just think about Interphex two or three years ago. There was a lot of stainless steel. Now it's all single use technology, and there's a lot of single use processing equipment out there.
Now, when you look at the facilities, everybody's talking about the modular, modular [INAUDIBLE 00:07:58], modular facilities. Modular is a good concept, and we don't see pods as the silver bullet. It's a tool in the toolbox of how clean rooms can be designed, how facilities can be designed.
But modular is just inflexible. You build a facility and that's it. You can't do anything about it. You cannot repurpose it, it cannot be moved. It's mothballed, most of the time. We've seen more and more clients asking, “We want to move it, we want to repurpose it, and we want to have multi products to it.”
It has to be flexible. Podification of facilities will accelerate in the next few years, and we are, I would say – it would supersede the modular facility concept. Podular will supersede the modular one. It absolutely will be the trend, because single use technology or the processing technology is only as flexible as the facility. With pods, you really have that flexibility.
Todd S: Amazing. It's a true disruptor.
Todd Y: I think it really is. In fact, Todd, I'm thinking about we've had the pleasure of working with a company in metro Atlanta, that had what they call a pod, but it's a piece of technology for water purification. They've installed it, literally, in a remote village in Peru in the Andes Mountains, a village of 200 people. Do you see applications like that, for the pod clean room? Any examples?
Maik: Well, it's maybe a dream, but the dream has to be – the ultimate dream also has to be that we can actually put these clean room pods onto trucks with one of these water utility pods also on the truck, run them in Africa from location to location, and create vaccines right at the location.
Todd S: We've got to get Rich connected with Maik. My gosh, what a fascinating, cool project that could be. Rich would love this guy.
Maik: I think really it's a dream, but it's a very realizable dream, in my opinion. I think it would be great, if we could do that going from location to location, create vaccines at these locations, and you don't have the coal chain problems, for example, when you ship vaccines. It's right there, in front of it.
Todd S: I'll be thinking about this interview well into the evening, I think. There's fascinating things to think about. Maik, 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 – Oh, Todd, are we allowed to talk about some aging facilities, too, did we not?
Todd Y: Is this another cheap shot at my advancing years?
Todd S: No, actually it is an excellent point. You're talking about the life span of the pods and mothballing facilities. The physical plants in the US, particularly, are getting old. What's the connection there?
Maik: It's actually not only getting older in the US. When you look just even into some of the Asian countries, which seem to be the emerging industries, they're already getting older. The aging facility is a hot topic. It's a very hot button. I'm the co-chair of the PDA task force on aging facilities, together with Glen Wright from Eli Lilly. It's a concern, because aging facilities are out there.
What do we do with them? How can they improve and optimize these facilities? How can they refurbish these facilities? Again, the pod concept fits very well into it, because instead of trying to refurbish an existing infrastructure of clean rooms within the facility, which you really most of the time can't do, you just rip that all out, you utilize the utilities that you ripped out, all these clean room infrastructure, and you slide the pods in, connect them to the existing utilities, and the aging facility is a modern facility.
Todd S: Fascinating conversation. Maik, this time I hate to say that we're out of time. Before we let you go, how can people get in touch with you and learn more about G-CON?
Maik: We are here at the Interphex, booth 2421, at the [INAUDIBLE 00:11:57] booth, but also best it's probably also to check our website, which is GCONBio.com. I'm in the [INAUDIBLE 00:12:05] really looking us up on the website, or contact me directly, via cell phone.
I'm also on LinkedIn. We have Twitter sites and LinkedIn sites, so we are really very visible out there. I always appreciate a phone call, an email. My email address is Mjornitz@GConBio.com. That's probably the best approach.
Todd S: Okay, Maik Jornitz, Chief Operating Officer with G-CON Manufacturing, Maik, it was great to have you. Thanks for stopping by and joining us.
Maik: Thank you very much.
Todd S: That wraps this broadcast on behalf of our guest, Maik Jornitz, my co-host, Todd Youngblood, I'm Todd Schnick. Life Science Connect Radio's live coverage from Interphex, we'll be right back.