This week, Spencer Kaufman (Midwest Machinery | Applications and Sales Engineer) and Jarrod Wrampe (CRB | Associate, Sr. Process Utility Engineer) discuss how the construction industry is helping with the rapid deployment of therapies and treatment for the new Coronavirus. In addition, they discuss Advanced Therapy Medicinal Products (ATMPs) and how they are manufactured.
Full Show Transcript
Brian Gomski (00:00):
Hey, Hey, Hey, what do you say? Engineering tomorrow podcast nation. This is Brian, your familiar host. And today we are traveling all the way to Kansas City, Missouri. That’s right, Kansas City, Missouri, where we are speaking with Spencer Kaufman, who is an awesome inside sales engineer at Midwest machinery, Kansas city, and Jarrod Wrampe. CRB does engineering, architecture, and construction in relation to biotechnology, pharmaceutical food, beverage science, and technology. It’s no secret we have a pandemic going on right now, Coronavirus, or COVID-19, however you would like to call it. CRB is working feverously with biotech firms and pharmaceutical companies to develop mass-produced treatment therapy, testing, and vaccines. You know, it’s amazing what the world can do when we all get together and focus on a solution for something, so stick around and we will see what CRB is doing to help in this fight
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Spencer Kaufman (01:32):
Okay, well, let’s go and get it started. So I’ll start off with introductions…
Jarrod, welcome to our engineering tomorrow podcasts, we’re super excited to have you. I know ever since we first had coffee and you, you started talking to me about your industry and what you, and what CRB does, I was instantly hooked and I’ve been reading articles and following you and CRB on LinkedIn ever since. And the content you guys put out is really, is really incredible and intriguing, especially with what we’ve got going on right now with COVID-19. So we’re really excited to have you, we know you’re here as a favor and that you have a lot of work to do to get back to, so we’ll try to keep it to the point, but I really think our audience is going to really enjoy what you have to say and, and kind of open the curtain a little bit on the behind the scenes work that goes on. So Jerry, Mr. Jarrod, do you want to introduce yourself and kind of explain your role at CRB, what you’ve done in the past, what you’re doing now and kind of how CRB differentiates themselves from other engineering firms and why they are so busy right now?
Jarrod Wrampe (02:46):
Sure. Thanks for, thanks for having me on guys. This is, you’re actually the second podcast that I’ve, that I’ve joined here in the, in the, since we’ve all been working from home. So it’s, uh, it’s kinda, it’s kinda surreal. So I’ve been at CRB, I’ve been at CRB for 19 years. I to came CRB straight from school. I graduated from K-State with a master’s in architectural engineering in 2001. What I’ve been doing for the last, well for most of my career has been critical utilities or processing utilities as we call them, which really all that means is it’s, uh, it’s mechanical engineering, but it’s all in, in the context of the evict process and in our case, it’s all bio-pharmaceutical processes. So I wrote more recently though, I have an actually, you know, course of my career, I dabbled in project management and had stopped doing that several years ago when, uh, we had the, you know, we had a billion-dollar project, uh, be constructed rod started around 20, 2013. So, uh, long story short is I’m back in the PM game. And because we’ve had a spate of, of, uh, COVID-19 projects blowing up all over the, all over the world. So we were in dire need of, uh, project managers and that’s where I’m, that’s where I’m losing sleep these days.
Spencer Kaufman (04:12):
Gotcha. So that’s where you’re sitting. So CRB, they kind of separate themselves by markets, right? So what are the, what are the main market segments that you guys separate your teams as they’re at CRB?
Jarrod Wrampe (04:24):
Sure. I am actually on the, uh, the biotech team in the Kansas City office. Uh, but our market segments are, biotech and pharmaceutical and then, uh, food and beverage, and in science and technology are the, uh, are our basic market segments. And so, I mean, you can get an idea for what those really mean, but we, we get a little more granular. Bio, biotech is, uh, is basically a biologically derived, or something that has to do with live cells or, uh, you know, genetic code or something like that. While pharmaceutical tends to focus more on API work, as well as, the fill, filling, and finishing of the product, getting it packaged and ready to be delivered. Science or technology is labs, uh, primary labs and academia, kind of the precursor to the work that we do in the manufacturing side and then food and beverage is, it’s self-explanatory. That’s our, that’s a relatively newest market space that we’re into is, uh, the, uh, food and beverage space, which is a pretty natural transition from all the hygienic piping and stuff we do in, uh, in biotech.
Spencer Kaufman (05:36):
Right. So for obvious reasons, I imagine it’s all hands on deck in the, in the biotech division right now, isn’t it?
Jarrod Wrampe (05:44):
It is. We actually have had multiple, a lot of my meetings are, uh, have been focused on this week about how we get resources to actually meet our timelines, because at this point, you know, even the, the Government is getting involved and asking for more than we were already doing. So it has become a, uh, it has become all hands on deck and, we’re, it’s, we’re in the mode of doing whatever’s necessary to get it done.
Spencer Kaufman (06:10):
Sure. That’s awesome. Well, the, not only the U.S. but I’m sure the world is super appreciative of what you guys are doing. And that’s another reason we wanted to have you guys on here is, is to make people aware, you know, all the behind the scenes work that goes on, even from an engineering perspective. So that takes me to my next point. I don’t want to make this an entirely about COVID-19 podcast, but I, I know a good chunk of it will be about that. But before we dive into that, can you kind of talk about the facilities design from maybe a 30,000 foot UV foot view when you’re talking about a pharmaceutical manufacturing facility or kind of the hot topic, the, the advanced therapy and medicinal products, when, when you’re talking about facilities for those, how does that differ from your standard run of the mill commercial building HVAC, you know, keeping people in an office comfortable, or your standard process at the local manufacturing facility down the street from the neighborhood, what’s different about it? What’s your role in that? And, you know, maybe what are some of the tough what’s the regulation environment like in, in that world, in that market?
Jarrod Wrampe (07:28):
Good questions. The first thing I would, I would…the place I normally start when comparing what we do to other consulting engineers or what other, what other people might be doing and, uh, building schools and hospitals and, and retail and those sorts of things. If you put it in the context of looking at the process and think in terms of a refinery or a chemical plant, those are processes. And the processes, the King pen is the center, the center hub of the wheel, if you will, right? So in, in a, uh, refinery or a chemical plant, those are outdoors. And you really don’t worry about comfort all that much, so though that that is pretty, uh, diametrically opposed to a commercial, engineered commercial facilities. Our case is that we actually, we, I, we have to design a process in the context of a building and keep humans safe and comfortable. So we have to take some of the, some of the more extreme parts of the process engineering, from process engineering perspective and integrate those into a building where we have, uh, a good amount of operations, but we also have a highly regulated environment. We can’t, we can’t build a biotech plant outside, uh, not, not one that is licensed by the FDA or EMA.
Spencer Kaufman (08:52):
Jarrod Wrampe (08:54):
There’s, there’s regulations that have to do with personnel flows and air quality, and pressurization schemes are extraordinarily important. And as what’s what is allowed to be done in different, different jurisdictions, whether it’s the United States or Europe, uh, there’s, there’s nuance there depending on where the facility is going to be built. So it does, it is fairly intensive and it’s more so, you know, our architects are, we call them process architects a lot of times because they not only have to understand their codes and how to build, but they also have to understand how the process actually works, right? Those, those adjacencies and everything are, are critical to make a facility that, that functions well.
Spencer Kaufman (09:40):
Right. They coincide together and you got to know both sides of it. And it sounds like, I mean, a lot of your customers and your clients operate on a global scale. So it’s not like you can just hang out in the USA codebook. You gotta be, you gotta be knowledgeable in all of that.
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Spencer Kaufman (10:11):
So you’re helping your clients, you know, put together these production facilities to, you know, to, to deliver medicines and pharmaceutical products, things of that nature, maybe even the containers for different types of pharmaceutical products or what have you. So that’s your standard run of the mill day in the life at CRB, but what happens when you have a global pandemic? Tell, tell us why, why you have been working from sunup to sundown and how has your dynamic changed now that you’re supporting these, these pharmaceutical companies that are trying to, uh, come and save the day for the people.
Jarrod Wrampe (10:48):
Why has it changed? Well, I mean, you’ve, you’ve heard in the news that people are talking about, uh, you know, concerned or anxious about when are we going to have a vaccine and then, you know, there’s other there’s therapies that are, that are being investigated their existing and being, uh, they’re looking for emergency use authorizations for those, for the people that have contracted the virus. But the vaccine is, is kind of the, that’s the thing that everyone’s pointing to is that once we have a vaccine, thanks can kind of go back to normal, so let’s get engaged by our clients, all over the U.S. and all over the world, uh, to come in and, and, you know, say they figured out a path forward on how they can, how it can be done. And there’s been a lot of development. I don’t know if you’ve kept up with, some of the news surrounding the rapid development of vaccines and, uh, you know, there’s one in particular that they’ve sequenced the genome. And, uh, and they came up with a vaccine candidate within 42 days or something from the time that they, the genome was sequenced, which was, which is really, really incredible. I mean, normally, uh, vaccines that, you know, can take a decade to develop a platform and what we’re, what we have today, and this kind of segues into the ATMP discussion too, is that the ability to, you know, manipulate the, you know, actually synthesize and manipulate the DNA or the RNA of the virus to be able to do this without actually growing the virus, which is why it’s, which is why it’s so interesting. So there’s a lot of cool, possibilities out there as a result.
Jarrod Wrampe (12:27):
And so while vaccines might take a very long time, we need it, we need this one, like immediately, right? So the reason we’re all so busy is because, you’ve probably heard it in the news that, you know, people are promising that we’re going to have a vaccine this fall. The earliest, when I started on my current project, the, the projection was running phase three clinical trial material, in, at the end of 2020, and having a phase three trial that would basically be quarter one of 2021. Now they’re pulled, they pulled that up about three months. So that’s, it was insane to try to get, to try to get a validated facility by the end of the year. But getting it, getting it done before the end of the year and running products that we’re putting in humans is, is really, really remarkable. So yeah, it’s definitely all hands on deck and we’re trying to figure out how we even ramp up our construction teams to, to be able to stay ahead.
Spencer Kaufman (13:30):
For those that don’t know, can you define what ATMP actually means?
Jarrod Wrampe (13:36):
Oh yeah. That’s the acronym for advanced therapeutic medicinal products, right. And really what that really, what that means is that these things are all, it really kind of, it kind of comes down to therapies that are derived specifically around using our bodies on immune system or genetic our genetic material to fight a disease. Sometimes it, it’s talking about, you know, giving, delivering a clean copy of a gene to, a patient who is, doesn’t have a functioning copy of that gene and, therefore, is causing a disease. And some of them are you’ll, you’ve heard of car T cell therapy. That’s, that’s a cancer treatment that’s, that uses the, that uses the patient’s own immune system. Uh, they basically, they will drop cells from the, from the patient and then process them and activate them, chemically and then reintroduce them in a way that makes it basically sensitizes them to the, cancer that’s in the body. So that’s using the, using the, uh, the power of our genome, as well as the power of our own immune system to fight cancer is really what these things come down to. And another term that gets used is personalized medicine, which is partially true in the world. There’s plenty of ATMPs that are, that are, want to be off the shelf. But a lot of the, a lot of the, the, uh, uh, therapies are, personalized.
Spencer Kaufman (15:11):
Gotcha. I guess this people would look at this as your day in the life job as a Process Engineer for a company like CRB. But to me, you guys are a part of global history here, and there’s a lot of other chefs in the kitchen that are supporting, you know, this, this, uh, pandemic, pandemic management and viral, and vaccine creation. But I mean, you guys are a big, big leg of the stool. That’s helping support the development of this vaccine, and it’s incredible what you guys are doing. So we appreciate it. I was reading an article that was put out by, by, uh, I can’t, I can’t remember the name, someone at your, uh, at CRB, and they talked about the three status strategies for successful ATMP facility design. And I don’t know if you read that article, but one of them, one of the strategies was focused on, you know, basically a modular construction approach so that you can take stuff that’s already been designed and slightly tweak it to meet the demand of your next process or whatever you’re trying to do. Have you guys been able to see that in action a lot with a lot of this accelerated design that’s happening and support, or can you speak on that a little bit?
Jarrod Wrampe (16:30):
Well, a lot of that action happens in the contract manufacturing realm. So there’s a lot of our, we have, we have a lot of clients that are the developers of their own, uh, therapy or their own vaccine, or they’re on drugs. But a lot of them are purely the developers of that, of that material over that, uh, science. And then they transfer that to a manufacturing contract manufacturing group that is, uh, responsible with recreating the, their process and producing them the, uh, the pharmaceutical product book, the book materials. So a lot of these facilities, especially in the, in that CMO world are, do work in a modular fashion, do work in a, in, you know, ballroom type suites that are, that can be plug and play and adapted quickly to different processes, ’cause they don’t actually have the process of their own. They develop one for their client and fit it in this space that they have. So, there’s a lot of that. I’ve been, I’ve worked on that, those kinds of projects for, for many years, and it’s in a ways that in some ways it’s very, it’s easy to distill it down, but it’s also, you know, if you start doing all the permutations that are necessary to serve multiple times types of processes within a, given a sweet, it does, it does balloon quickly. So, there is that, that is a big part of, of ATMP is that contract manufacturing, component. But, uh, yeah, that’s, that’s who we work with quite a bit and the modular clean rooms and that sort of thing is a, is a great concept and can be used, used pretty, pretty well when you have time. But unfortunately, a lot of those, those things function like a piece of equipment. So it does take time to get them. So right now there’s no capacity. Nobody has any, all the manufacturers of those, of those, uh, modular, clean rooms, they’re backed up and I can’t, they wouldn’t be able to hit the timeline to do it this year.
Spencer Kaufman (18:38):
Right. That’s crazy. All, all supply chains are being, are being stretched then that is for sure. So would the use of antibodies from plasma of a recovered COVID-19 patient to help current COVID-19 patient? Would that be considered a, an ATMP?
Jarrod Wrampe (19:00):
No. Because you’re, you’re dealing with a, you’re dealing with plasma itself and you’re not, you’re not changing it appreciably. So, we do a lot of work in plasma fractionation as well, and that’s really been where I’ve spent a lot of my career. There, there’s a lot of, uh, there’s a lot of therapies out there that you don’t realize that are, that are human plasma-derived. And, and so if you go to bio life or, CSL to donate plasma, that ends up in, in pharmaceutical products. So, bio is actually associated with, with Takeda. So, you’ve may have, may have heard that there’s a, there’s a coalition right now. I, and I’m blanking on the other names, but CSL and Takeda are actually working together to pool all of that, all the, uh, COVID-19 plasma donations and, uh, create a process for a hyperimmune globulin, which would basically deliver those, those, uh, the plasma that would deliver an immune response or give the, give the patient an ability to fight, uh, the infection. Wow. So it’s not a, it’s more of a refinement process than it is a, uh, than it is a, uh, uh, genetically, you know, genetically modifying. So it’s, it’s a different branch of, of the, uh, uh, basically how you, how from a regulatory perspective, plasma is, is kind of in a different branch than, say, you know, these advanced therapies that were, were significantly modifying before reintroducing.
Spencer Kaufman (20:38):
That’s crazy. I’m having a little bit of deja vu come through my head that I just have to voice. It’s kind of, since we’re both case Staters, I don’t know if the plasma bank was there when you were there, but it was a very common site on campus to see, uh, folks with the little cotton swab and tape on their arm, because that was a main source of income for a lot of college students was to donate plasma. And the irony of the whole situation is we need plasma, from past patients, but the schools are shut down, I guess, get past patients pretty easily if they ever went to the hospital. But it’s just a little bit of irony and deja vu running through my head, from the K-State era.
Jarrod Wrampe (21:26):
Yeah. Yeah, that’s a, that is a good, I mean, that’s part of the, it’s part of the reason why the testing and everything is important to know who’s actually had it and recovered so that we can, so that we can go, uh, you know, beg for their donations.
Spencer Kaufman (21:39):
You touched on something earlier that kinda had a question, uh, pop up in my head. We talked about going from that modular design with the ATMP and taking something that’s been kind of developed in the lab in a, in a small, you know, academia lab typesetting, or maybe even, uh, a pharmaceutical company, R and D setting. Is it difficult? Do you guys see, or get involved on taking that process to manufacture that product in a small scale, uh, scenario and taking that to a large scale and mass production of that? I mean, is, is there a lot of difficulty taking that processing and magnifying it
Jarrod Wrampe (22:22):
So specifically in the cell therapy world, you know, we’re talking ATNPs and everything, that, that is the absolute problem is, uh, what you, we talk about scale up a lot of times with traditional, uh, biotech and traditional, uh, pharmaceutical processes is how big do I have to make it, to get the throughput that I need. When we’re dealing with personalized medicine and cell therapies that are each patient is an individual lot or an individual batch, you can’t scale up, you can only scale out. So there’s a lot of manual processes that are, that are used in, at the development scale that don’t translate well to commercial manufacturing.
Spencer Kaufman (23:06):
Gotcha. It’s like a bill order if you will.
Jarrod Wrampe (23:09):
Yeah. It’s, it’s, it absolutely is. And it’s a lot of, a lot of hands touching it. So, you know, of course the next level is, the next, the next level of development is talking about robotics and how do we, how do we automate these things to reduce human interaction and get more clients or more patient deaths in our facilities so that we can, we can actually be efficient at making these things cause the way it is now, you’re absolutely the right. That’s the biggest challenge for a lot of, a lot of cell therapies is the scaling out is, is, uh, is a huge issue.
Spencer Kaufman (23:46):
So Jarrod can, can you tell us a little bit about CRB and the construction side of the business and the design build label, if you will, and how CRB can, can help with, uh, not only designing, but construction, constructing a facility as well?
Jarrod Wrampe (24:05):
CRB is not just an engineering and architecture company. We are a construction company too. So, something that is, that is, that is critical in these hyper-fast projects. Like this is, the ability to integrate or to overlap, or maybe even do concurrently design and construction activities. So, for, everybody’s probably familiar with the term design-build, which is a misnomer, in some ways for what we do, because ours is really more along the lines of an integrated project delivery, which involves heavy, uh, heavy involvement from an owner, as well as a design and, and construction traits. So, there’s many different models out there, but, that’s something that we’ve, we’ve actually gotten quite good at, especially on these fast-paced projects. And we’re going to have a, have a great story to tell here in, uh, here by the end of the year,
Brian Gomski (25:01):
that was a great episode with Spencer and Jared. And it’s awesome to kind of look behind the curtain and see how hard everyone’s working to squash this stupid virus. You know, you see the headlines, but you don’t get to see a lot of the people working really hard behind the scenes. So I’m incredibly thankful for Jared for getting on this podcast and sharing some great news and hope and how hard everyone’s working to get this taken care of. Again, thanks for listening until next time. Keep engineering for tomorrow today.
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