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Chris Weikart: Medical Glass, Materials Science & the COVID Vaccine Supply Chain | Transcript

Full episode transcript below. Beware of typos!

Nick Jikomes

Dr. Chris Weikart. Thank you for joining me.

Christopher Weikart 3:39

Thank you, Nick. It's pleasure to be here.

Nick Jikomes 3:41

Can you start by just telling everyone who you are, what your background is and and what you're doing professionally?

Christopher Weikart 3:49

Yes, I'm Chris Weikart, and I'm the Chief Scientist at SiO2 material science and basically work for a company that manufactures primary containers, things like vials, syringes, and cartridges for liquid injectable drug products.

Nick Jikomes 4:08

Interesting. So a lot of what we're going to talk about today has to do with the vials that you're making, and in particular, the vials that you're making for some of the COVID vaccines that are in wide circulation right now. So you said the company is SiO2 in your materials science company. So can you give us an overview on what exactly materials sciences?

Christopher Weikart 4:30

Yeah, the name of the company may be a bit strange so that maybe we just start with the SHA two piece. SHA two is actually a chemical formula for silicon dioxide, which is a key ingredient of glass. So we we are a material science company, meaning that we develop products, utilizing material science as a scientific field. So we're very good at understanding how materials how to manufacture materials. and make them work for, for packaging of, as I said, drug products, in particular biologic drugs, we use a polymer container. And then we put a microscopic layer of a glassy like material on the inside, which is this co2 component.

Nick Jikomes 5:18

So my understanding is, you know, historically, there's been a lot of different use cases, for different types of materials for things like liquid injectables, and just to store medicines. And so at a very high level, you could have a vial or packaging that's made out of some kind of plastic polymer. And then you can have things that are made out of glass. So before we get into the specifics of what you guys have innovated in exactly how you are manufacturing, the vials that we're going to talk about, can you give us maybe maybe a historical synopsis on how drug packaging has sort of evolved in your lifetime? And the extent to which plastics versus glass tend to be used?

Christopher Weikart 5:59

Sure, sure. Yeah, it's, it's interesting. I mean, so, you know, glass has been used for for a very long time, I mean, for, certainly for hundreds of years, and more recently, is used predominantly in the packaging of drug products, and particularly liquid injectable drugs. And it's certainly been the material choice in the form of vials and syringes and so forth. Plastics, being a more a newer material, of course, it was invented at the dawn of World War Two. And, and, and it has since penetrated many markets, but it really is not a good material in itself, for packaging, these types of drugs. So glass, again, just historically, people think it's a NERT. It's a pretty strong material, and has been used a long time. So therefore, they they use it now, drug products have evolved a lot over the years. And more recently, you hear more about a class of drugs called biologics. These are drugs that are actually derived from living cells. So they have cells will produce things like proteins and peptides, and those are harvested, and injected into folks to treat a lot of different diseases. And what they find is, these are complex drugs that have evolved over over the course of decades, have special packaging needs, and glass, probably not the best material. Even plastic alone is not the best material. The reason why is because glass, for instance, can break, it can leach materials into the drug product, and certainly even plastics can they're not ultimately a very clean product. So what we've done is we've kind of invented a new hybrid material that takes advantage of the the advantages of glass and the advantages of plastic, and then fuse those together into a new product. Without the those materials disadvantages. And so we basically sell a product that's ready to fill, it's clean, sterile, gets rid of any leachables, or anything that can contaminate the drug product, which you'd commonly find in both glass and plastic. And it's unbreakable. It's, it's tough, resilient, and can can stand the test of time. So that's what our products are about. And it's, it's really a revolutionary type of packaging. And we've been promoting it for about the past 10 years. So the company started in 2011. And we spent a good deal of that time developing the product, I'd say about half that time was a lot of r&d, investment. And, and now we're in a in a very much in a commercial stage and selling our product to a variety of customers.

Nick Jikomes 9:00

I see so so if I'm understanding that the driving force for for why you guys started and why you guys wanted to build this kind of hybrid container was that as biologics became more and more common, more widely used, there was greater need for this type of products because this material can be contaminated by things like bleaching through something that's only made of glass or plastic. And those things just don't contain biologics in the way that that ideally you need them.

Christopher Weikart 9:30

Yeah, I think it really boils down to managing the stability of these new drug products, as they said they're ultimately very sensitive. They have special needs. And yeah, I mean, certainly there are a lot of drugs that are packaged in glass today. The dump the market is dominated by it. And there had been improvements. I'd say they're step change improvements in glass to try to take a band aid approach to solving a lot of these problems, but also similarly, you still have to deal with them. And what we do is we offer something new that basically eliminates a lot of these issues, as they said, breakage leachables into the drug formulation. And I think that's what's unique about us. Now, the industry has been entrenched with glass for so long, they're, they're pretty, pretty resilient, resistant to change. And when you've invested a lot of time and money and effort in installing glass into your, your packaging, we can understand why they're resistant to change. So ordinarily, we, it's very difficult to transition existing drug, especially if it's a blockbuster drug, that's, you know, billion dollars investment over to a new package, because there's always obviously risks associated with that. So we've been focusing a lot of a lot of our efforts on early phase development drugs, these are in phase one or phase two clinical trials, where a company would be more receptive to introducing a new package, like own and it's a lot easier to make those sorts of transitions. I think a good example of that would be some of the the COVID COVID-19. vaccines that have more recently been or news to the to the marketplace. And of course, we're selling into that market, as we stand today, particularly for Maderna.

Nick Jikomes 11:31

You Yeah, I'd like to talk about some of that stuff. Before we get there. I would love to understand the process, like how you guys actually build these hybrid products, I think maybe a good lead into that could be, if you just describe for us, you know, to someone who doesn't know anything about this, which includes myself, basically, what at the molecular level, what is just regular old glass and how it's made? And how does that differ from what plastic is and how it's made?

Christopher Weikart 12:00

Yeah, yeah. Yeah. So I mean, your ordinary glass, that most of us come in contact with, is not what they're using for, for packaging these drugs. So the class of the glass, or the materials that are glass that are used is what's called oral silicate. Okay, so that's something that actually was invented in around 1880, believe it or not, by, by shot glass. And that's been used for a lot of different things, including thing of drug products. And it has basically silica, the SHA two that's in our company name, and a bunch of other what I call metal oxides, things like boron are also looking at obviously, is the name of it. And other metal oxides that help you process the glass makes it a little more resistant to the things you put in the glass, because glass can leach things into the contents. And basically, also, again, as again, it's been that sort of mainstay material in the industry. What we do is obviously very, very different. We're molding a plastic container, and then we're putting a microscopic layer of glass like material on the inside of our containers, which is completely different from what's done today. With with glass vials and syringes.

Nick Jikomes 13:29

Yeah, can you go into a little bit more detail on on the process for making this here and really kind of unpack for us? What, what level of resolution are we talking about here? So when you talk about putting these coats on plastic, How thick are these layers? And what is the the nitty gritty in terms of how that's made?

Christopher Weikart 13:47

Yeah, so we start off with, with a polymer. And that's, of course molded into the various files, syringes, and so on. But not not not too different than the process that's used to mold like your beverage container for for various colas and water. A similar process that's used. We do use a polymer that is medical grade. So it's a very clean resin. It's basically highly transparent. I mean, if you put our vial next to a glass file, with the untrained eye, it'd be very difficult to tell the difference. So they look very similar. We given it's a polymer it's about half the weight of a normal glass vial. And then of course, after the the vial is made, or the syringe we put this, as you said, this microscopic layer on the inside. And we use a technology that actually is more similar to the manufacturing of Mike electronic devices. So microchips that all the the processors that are in your computer and your iPhone and other electronics, we use a process that's very similar to that to put On this microscopic layer, the layer itself is actually made of three layers in totality, it's about 800 times to 1000 times thinner than a human hair. And so it's very, very thin, you cannot see it, as he said, microscopic. So you need some some, some very sophisticated techniques to analyze it insurance there, and to make sure that every single vial and syringe or whatever we're making, its its present and it does its job. So the process is, is kind of it's referred to as a Plasma. So we think of like, the various phases of, of materials around us, we think of solids, we think of liquids, we think of gases. And there's always that fourth state that we don't think about too much about it's called plasma, we used to actually utilize plasmas to put down these very, very thin microscopic layers on the inside of the container, it basically lines, the inside of the container to protect the drug product from plastic. It's ultra pure, it's it's obviously very, very thin. And it's highly energy far more nervous than ordinary glass.

Nick Jikomes 16:16

So you're basically painting an extremely thin layer of glass onto a plastic vial. Presumably, the reason that you use the plastic vial at all is because it's easily moldable and mapable. But then this thin layer of glass is super thin, but also super strong. And it's basically when you say it's a NERT, you just mean, there's no sort of chemical reactions can happen between the biologic that you're putting inside the vial and the actual glass layer itself, and then also nothing can leach in from the outside?

Christopher Weikart 16:48

You got it? I mean, you're really summarize that very well. I mean, so the the polymer, just take the power, why do we use it? I told you it was medical grade, I told you was very clean. But it's really, really tough, they can take a ton of abuse far more than glass can. Now glass is a is a strong material. But when you mold it into things like vials and syringes, there's always defects. And those defects can lead to breakage, it's quite common, more common than we think it can. If you know, for instance, if you were to break one single vial, or even a syringe for a drug, that's maybe $1,000 per dose, not uncommon for these, these biologic drugs can be quite expensive. You obviously don't want it to break. So our vials and syringes can take a tremendous amount of abuse. And that's where the polymer comes in. And because it's a polymer, and it this, most polymers have additives in them, and you don't want those additives, contaminating the drug. So this is where the coating comes in. The coating is I said, as you said, highly inert, doesn't contaminate the drug product, more more nerve than most other materials that you might come in contact with. Very, very resilient, very toxic and take the kind of abuse the vial is going to see, even though it's very, very thin. And we've engineered it in a way such that it minimizes any interaction with that drug product, the active ingredient in there that the patient's going to see, you don't want to lose any of it, you don't want any of it sticking to the side of the vial, you don't want it to turn into a ball of, of what we call aggregates can be very common in glass. All of those things are eliminated by by by the the decoding that we put on the inside. And this is where material science comes in. And it's material science is basically the study of materials and leveraging their advantages by combining them in different ways. And that's that's basically what we've done by basically engineering it with the right composition, the right chemistry and the right thickness to protect and preserve the drug product.

Nick Jikomes 19:03

Yeah, and you mentioned that you were working with some of the or your vials are used to as containers for some of the new mRNA vaccines that are used for COVID. My understanding what those so a I mean, that's a biologic, it's a lipid encapsulated mRNA molecule, that's, that's going to be in the vial. My understanding, too, is that those need to be stored at very cold temperatures. And I wonder if that's relevant here in terms of how these vials would hold up at such a cold temperature compared to traditional glass?

Christopher Weikart 19:34

Yeah, there's there's interesting challenges there because the temperatures are so cold. You know, for instance, the the Maderna vaccine, I think initially they they required it to be stored at minus 20 degrees Celsius, and that's that's really, really cold. Pfizer required it initially to be stored at minus 70. I mean, that's even colder, right. So and then there is There's other therapies that even require even colder temperatures down to cryogenic temperatures which can reach, you know, minus 180. It seems extreme, but really the whole idea there is, again to preserve it so that it can be then reconstituted and then injected into a patient. So the problem with glass, when it comes to those temperatures is remember, not only do you have a vial a glass container vial, you also have this rubber stopper that has to be inserted into the top of that vial. And as the temperature drops, those two materials, this rubber, rubbery material in this glass, which are very, very different, and what ends up happening to the rubber is actually starts to harden, and it starts to shrink, and glass and rubber shrink at different rates. So it's quite possible that you could get a leak, it can't happen if they're not matched appropriately. And it's, it's an issue that they have to deal with. It's not an issue with our vial, because you have a polymer, and you have a rubber material, they're very similar in some ways. So they shrink at the same rates, they're better matched in terms of sealing. And so your propensity for leakage is far reduced. Also, the propensity for breakage at these temperatures, can be can be higher for glass than then for our polymer. So there's quite a few advantages that we can leverage and in our product to showcase to our customers and return to being one

Nick Jikomes 21:37

of them. So how long does it take you to make a vial compared to a normal glass vial?

Christopher Weikart 21:42

Yeah, our our lions are are capable of very, very fast throughput. I can just tell you so about, you know, before the COVID pandemic came along, we were producing probably on the order of about 10 million miles a year, or 10 million of various container size vials a year. Once, we were very fortunate to get some government funded money through operation works Thiede, we got about $143 million. That was for expanding our capacity. In Auburn, Alabama, where we're located, we basically went from 10 million miles a year to 10 million vials a month. And that was because of our ability to expand production capacity. So in terms of comparison, our throughput, I mean, it's really unlimited. I mean, it's, you know, obviously, you need money to build additional capacity. But, but we have very, very fast through quit machines, that mold coat, package them, and then the only thing we don't do on site is the sterilization, we send that out to a third party to be sterilized. And that's one thing we haven't mentioned is the ability to fill our, our, our containers, because they're already they already are sterile glass typically is manufactured dirty, that like they intend to do that. But before it's it's a dirty product that has to be sterilized and washed before it can be used all wine fulfill and finish are ours is ready to use when we call it RTU ready to use, because it is already already sterile and ready to fill with the drug product.

Nick Jikomes 23:35

I see. So you mentioned Maderna was using your vials, so So basically, are you selling directly to like the vaccine manufacturer or the drug company themselves? And they're just ordering, you know, one or five or 10 million vials? And then that could ship to be sterilized that goes to them to be filled? Is that like the order of operations?

Christopher Weikart 23:58

Yeah, so I mean, so right there, just to be clear, Maderna has multiple suppliers with them. I think the demand, obviously, for so many of these vials, you know, in our ability to expand our production capabilities, it certainly exceeded their, their their needs, so, so they have multiple vendors, no question about it. But so what they're the ones that procure them from us, we ship them not to Maderna where they make the vaccine, but we ship it to their, what they call their CMO or their contract manufacturing organization. This would be the company that would do the fill finish. So that's what we shipped directly to them. And they are the ones that do the filling and the finishing and the capping and the labeling of the product before it goes out. So while we're doing purchases from us, we don't ship directly to them, we send it to what they call their CMO.

Nick Jikomes 24:59

Now As a more general question here, you know, everyone, in almost any business that you might be in, or even just ordinary people have felt in some way, the effects of a lot of the supply chain supply chain shocks that we've experienced in the last couple of years, is there have you guys or other glass companies experience any of that in terms of getting your raw materials, what's been what have been the constraints, there's anything slowed you down the last two years?

Christopher Weikart 25:26

You know, it really hasn't. And, of course, there has been a shortage of glass for the glass industry. This has been reported on for quite some time now. And it's been, it's certainly hindered glass company's ability to fulfill the demand for folks like Pfizer and Maderna. And, of course, you still have this, this growing biologic drug market that continues to grow. So we have actually zero ties to any sort of glass raw materials. And I know it seems a bit odd, because we we do put down material that is that is like glass, but are so obviously we as I said, we started with a polymer. So that's obviously not glass. The glassy material that goes down on every vial and syringe is more closely tied, again, to the microelectronics industry, they actually use liquids, that ends up becoming a gas in a process and converted into a solid as a class like material. We use the same raw materials as, as they are manufacture of the microchips that are in the computer, or,

Nick Jikomes 26:45

and what is that? Like? What is the molecular formula of this material?

Christopher Weikart 26:49

Yeah, it's, it's referred to as an organic, no Seiling. And as they said, You can buy it from a number of different manufacturers. But you got to remember, you know, the amount of material that goes down on each and every vial and syringe, we said it was on a microscopic scale. So let's just take one vial, for instance, our typical vial may be only six grams, okay, in total, after it's coated, about 400 micrograms of that is coating. So the materials for the coating are miniscule compared to the vial itself. So as I said, completely no ties to the glass industry in terms of raw materials, and no problem with gaining access to those for our manufacture vial. So it hasn't been a hindrance whatsoever.

Nick Jikomes 27:45

Interesting. Okay, so So you're basically not slowed down by anything, in part, because these layers of material are so small, that you've probably just got some enormous, relatively enormous stockpile, that's gonna last you a very long time.

Christopher Weikart 27:58

That's right. That's right. You'd be surprised we have a, basically a small canister that connected to one of our manufacturing lines, it's everybody looks at it like wow, that's, that's not very much. But if you think again, about how much material actually goes down, a little goes a long way in our products. And we certainly take advantage of that.

Nick Jikomes 28:20

So is this is this the only thing you guys make? Are you specialized for like vaccine vials?

Christopher Weikart 28:27

No, not really, actually are, as I said before, our focus previously was on a variety of different biologic drugs, that we're completely outside of the realm of this, this vaccine market, only because of the pandemic that we shift our focus over to this, but we do make a bunch of other products for, you know, as they said, a variety of different biologic drugs, but we also have, interestingly enough, a baby bottle that takes care and basically takes advantage of this same technology, it's sort of a, you know, again, a lot of mothers don't want their babies milk in contact with with a polymer, there's certainly some negative connotations of things leaching into the baby's milk. So we do sell a baby bottle product, we have a line of, of products for the laboratory, for instance, blood collection tubes, again, leveraging the same technology, align aligned polymeric blood collection tube, so you don't want anything getting into the blood. That's, that's that's pulled into the tube, and many other things microtiter plates, collection tubes of various sorts for the laboratory.

Nick Jikomes 29:47

How I mean, I really know nothing about this area. So when we're thinking about like everyday plastics that would be used in something like a baby bottle, or just you know, I've got a I've got a cup here that's made out of something kind of plastic. What is can you give us a sense for like, what the actual risk level is, in terms of things leaching out like the polymer polymer is actually coming off into the liquid you might be drinking or stuff coming through from the outside. Is that is that a major issue? Or is it a sort of a rare occurrence?

Christopher Weikart 30:19

Well, I mean, I certainly the FDA regulates this for foods and beverages. So I think the risk profile there is quite low. But there certainly is the perception, I just use baby vols as an example. And there's certainly have been reports of things in baby bottles that are not good for for baby. I mean, and I'm certainly not here to claim that's true or false. But certainly the perception is reality for a lot of folks. And we basically serve that we can provide a product that can be certain that nothing contaminates that milk, whether it's harmful or not, I cannot say but I can certainly ensure that there's nothing getting into that milk. And that gives a mother's, you know, certainly a level of confidence in our price, reason why they buy our product. And that's something new that we just recently introduced last year, again, leveraging that same technology, I mean, for drugs, it's a little bit different. And I think the risk profile error is much, much higher, because if you alter that drug, as they said, these biologics are very complex, they can result in in bad things. And, you know, for instance, could solicit an immune response in a patient. Again, remember, you're injecting these directly into your bloodstream. If the drug is not in a state to help the patient, it can be perceived by the body as a foreign invader. And it can trigger an immune response to anything from anaphylactic shock to a rash, and even potentially death. Now, the risks are on the low end, but I need if it's your mom, or your sister, or your brother, or I need you, what do you want, I know you're going to want to go with something that's not going to have that kind of risk profile. The drug companies obviously manage that risk. But we obviously can reduce that risk burden much, much lower than standard packaging.

Nick Jikomes 32:27

I see. So you mentioned that like a company like Maderna has multiple suppliers of the vials that are using so some of you know if you know if a million people that got the Maderna vaccine, were you were talking to them, some fraction of them would have had one that was stored in one of your vials, some fraction of them would have had one stored and another kind of vial that was maybe more standard medical glass and so on and so forth. I mean, is it conceivable that there would be different rates of contamination for the same exact vaccine in this case, based on what it was actually stored in? Yeah,

Christopher Weikart 33:04

it certainly the there would be differences Maderna, obviously, getting some some glass products I know. And there's been public disclosures on a Corning Glass supplying a new type of glass, a new glass that lowers the the leachables bird meaning the left less contamination into the product. So, but it's no breaks, you know, it still has other issues. As I said before, our product does eliminate a lot of those issues. So there are some new products coming online, the new materials, but I as I said before, they're more of a band aid approach, in my opinion, they're really not eliminating these types of problems. But again, you know, I think for modern and Pfizer, the demand is just so high at this point in time, that they're, they're pulling products from various locations. I think, once this supply chain issue settles down, they're gonna have to choose or decide upon a given platform. And we certainly think we offer the best products for for their, for their vaccine, and certainly hope that they'll choose us for for anything they develop in the future. And we gotta remember before the pandemic came along, they weren't even focused on on COVID. They had a whole line of very interesting and innovative drug products based on this mRNA technology. Very exciting stuff. All of their attention, obviously, is is on this, this vaccine for COVID. But I think it's going to swing the other way. And again, you're going to need new innovative packaging. I think we provide that.

Nick Jikomes 34:51

Yeah. I'd be interested now. So if I think back to when I was in college, I didn't study material science, but I remember it was something that could major in. And I think, you know, it was relatively new at the time. For those people who are listening that are unfamiliar, especially people that may be students or might become college students in the near future. Can you talk about what material science is in terms of what, what basic scientific disciplines do you learn about to to become a material scientist?

Christopher Weikart 35:24

Yeah, that's a good question. Yeah, you can certainly major in material science and engineering, there's a lot of schools that offer this at major universities across across the country and in the world. But basically, as they said, it's basically a study of materials and understanding their, their chemistry. So you, chemistry is obviously a discipline that can be leveraged here, not just on the molecular level, but but also at a higher level. And then there's the physical properties of materials, you know, how do they interact with other materials? In our case, it's drugs? How do they handle abuse? How do they handle temperature cycling? If you put a chemical inside it, and how do they interact? So there's certainly some physics, there's chemistry, certainly math, and engineering. So and that's really where problem solving comes in? How do you invent a better package? And and what should that look like? And as I said, I go back to really understanding the advantages of glass and, and the advantages of plastics. And they both they both have clear advantages. And they've been leveraged for decades for all kinds of things that surround us in everyday life. So how do you how do you how do you combine those advantages and, but not have the disadvantages? And that's where you have to understand a little bit about engineering. How do you combine materials that ordinarily shouldn't be combined or are ordinarily combined into a product. So problem solving, and, and bringing engineering to solve those problems, using chemistry, physics and mathematics are key. And there's a whole field of science around various materials polymer as being one of them. So polymer science we bring to bear here, and then a whole field of, of material science in what we call thin film technology. So as I said, everything from what's in your microprocessors to coatings that go on, say anti reflective coatings that go on your glasses, or coatings that go on windows for, for reflecting light, all of that science is leveraged in the microscopic layer that we put down on each and every container. So a lot of a lot of disciplines haven't been brought to bear in studying materials, and again, exploiting their benefits.

Nick Jikomes 38:07

Interesting, yes, it's really sort of a material science, I think it's fair to say is applied math, physics and chemistry. And then of course, in many cases, there's a component of biology there as well, because you have to understand what you're actually putting in into these materials.

Christopher Weikart 38:21

Yeah, no, absolutely. And that's a component that's it's a little more difficult, because of course, when you're working with some of these drug companies, they're not going to tell you basically their secret sauce, if you will, or their secret recipe. But they'll maybe give you some idea of of what sort of when we certainly know a lot of these drugs are based on proteins and peptides and amino acids that are assembled together in different ways. But they're not going to tell you exactly in some cases, they can't tell you exactly because these molecules are so complex, but But yeah, certainly understanding the biological significance of these drug products, and how they interact in a formulation can really help understand how they're going to behave in your package. So there's some surface science and some interfacial science, as we call it, of how a surface will interact with a drug formulation. You don't have to think about that too much for some of the less complex drugs, but in the field of biologics, it's very, very important to understand that.

Nick Jikomes 39:28

I see. So is it true that you know, for biologics, for things like vaccines, that there's not necessarily like one material that would be ideal for all biologics that that you might put into these things? You might, in theory to want to, like, customize it to each thing?

Christopher Weikart 39:46

Yeah. And I'm glad you brought that up. Because I think for the vast majority of price we've encountered you know, our product has been just fine. But there have been specific some specific cases where we've actually had to engineer the surface of our code. To say minimize interaction, some drugs are quite different. And they do interact in ways you wouldn't expect. But we can change the surface of the container to minimize those interactions. It's one of the advantages over the technology that we can, as I said, bring some surface engineering, to bear to to minimize anything that that might cause damage or change the drug product, that has been a small percentage of the products that we've encountered. But still significant. And maybe in the difference of, of introducing a drug to the drug to the, to the marketplace or not. And in some few cases, we've been able to showcase those advantages to our customers.

Nick Jikomes 40:50

I imagine, like on your team, you've got different kinds of scientists doing different kinds of things. Can you give us a sense for like, what are some of the key scientific roles? And what are those people doing? How much of it is, you know, intellectual work versus, you know, actual hands on work to say, build, build some device? That's part of your manufacturing chain?

Christopher Weikart 41:12

Yeah, so I mean, that's changed quite a bit over the years, we've been around, I mean, initially was a lot of focus around research and development. And so there was obviously a lot of bench, but I call benchtop work, understanding, you know, what are these processes going to look like? You know, bringing, again, utilizing material science to understand what is our product ultimately going to look like? And how does it address all these problems with stick with current packaging? Okay, so, first four or five years, a lot of research development to understand what the products gonna look like, what what the manufacturing process might look like, then the next five or so years, we brought a lot of more engineering to bear, or to scale up the, the process, because, you know, initially, we were coding, you know, they won, we were we were coding and manufacturing bottles, you know, two bottles at a time, then 10 bottles at a time, you know? And then of course, obviously, how do you mass produce that, with millions of containers utilizing a technology that may not seem very obvious how you would you would scale that up? Right. I mean, so today, I think the, the workforce has changed from the standpoint of, we have a lot of folks fixing problems that were specific to the drug industry. And then later on, it was more about how you fix problems for scale up and mass production. So we do have a lot of engineering folks with in the areas of mechanical engineering, chemical engineering, automation, because a lot of our manufacturing has a ton of automation. This is, or these are in cleanroom environments. So you want to keep manufacturing, free of particulates, it needs to be sterile. And we do have a lot of robots. So automation, engineering, and programmers have to be brought to bear to eliminate human contact with with our products to keep it sterile. So it's interesting how a company first starts because I was literally employee number six. And, and now we're, we have a company of 500. So, again, the company evolves and you have to change the workforce accordingly to to address what stage you're in and commercializing the product.

Nick Jikomes 43:45

But you have a lot of people that basically, you know, if they have college degree, they probably studied something like engineering or something like physics.

Christopher Weikart 43:53

Yep. Yeah, as I said, I think the majority of folks that are working in our production areas and and that the equipment have engineering degrees, as I said, mechanical engineering being one of them Computer Engineering, being another industrial engineering and another chemical engineering on one of the on the coding side. But, but all of those disciplines are brought to bear we do have a lot of molding engineers. They have they maybe have their sort of their bread and butter is mechanical engineering, but they specialized in how to mold polymers into containers. Now, there's a whole discipline around that as well.

Nick Jikomes 44:33

How did you actually get involved with this company? Was this something that you expected to happen or what was sort of your origin story with respect to getting into this line of business?

Christopher Weikart 44:41

Yeah. So I originally worked at the Dow Chemical Company in Midland, Michigan for about 11 years. This certainly was not on my radar. What happened actually was one of my former bosses at Dow and had retired and left the company and got in touch with me, because he was consulting for a company down here in Auburn, Alabama. And they had this idea of starting a brand new business centered around a new and innovative packaging for for drug products. And, of course, the focus being on biologic drugs. I certainly was not looking at that time, I, I couldn't even tell you where Auburn, Alabama was on the map. So that that had to be figured out first, but, but I came down, and I really, I really liked sort of their vision of what they wanted to create, at Dow as I was part of core r&d. So I got, I got to be involved in a lot of new products, but never really saw it to the very end, which is exciting itself, but sort of, you know, you'll love to see something, you know, be a part of that path, to developing something all the way through to commercialization and sale, that that was an opportunity for me to be a part of that, that journey, from early conception, all the way to to commercialization. So I think that really excited me that I could be a part of that process. And Ernie, there was a very strong connection with the Dow connection, a Dow Chemical Company from a consulting standpoint. So I knew a few of the individuals that were consulting with our owner, body, Abrams, and, and they were all obviously part of the decision making process for me to make that jump down here to something completely new and different with a company that only had five employees. So I had to do a little bit of understanding of what I was getting into before I made the journey, but I certainly don't regret it. It's been a it's been a great ride. And I continue to see new applications for this technology. And I'm certainly part of that, that journey.

Nick Jikomes 46:54

Another thing I'm interested in is, so you mentioned that you got you guys got government funding, as part of the larger operation warp speed effort around just vaccine, you know, scaling up vaccine production in every way that we need it right now. How does, I'm curious about how that actually works. So like I work in the private sector, and we have investors who, you know, give the company money because they expect there to be growth, and they'll get a financial return? How does? How does the relationship with the government work here in terms of how they determine who to give money, how much to give? And if they're, they're not investors in the same way that you would get at a startup, you know, getting money from investors. So how are they measuring like their return here? What does that actually mean for the government?

Christopher Weikart 47:39

Yeah, yeah. So obviously, we're one of many companies that received funds to expand production to assist with the, the COVID pandemic. So, you know, basically, we worked through an organization called BARDA. And they were the ones that we had contacted, and, you know, basically submitted a proposal that we could certainly assist in, in the production of containers for for the vaccine itself. So there was money allocated, obviously, to companies developing the vaccine, those that were packaging the vaccine and other entities as well. So I think for the government, you know, they wanted to obviously, assist in any way they could, this is actually grant money. So it's not money that requires repayment, it's it's, as you said, it's different from investment, for or from an investor putting dollars in. But basically, it's all straight to capital investment machines to build equipment that will ultimately manufacture these, these containers, and also, of course, at the buildings, and so on and so forth. So, yeah, we initially got $143 million for the expansion. And then just earlier this year, we got another $63 million dollars, again, for additional expansion and capacity. Again, all to address the demand for these containers. But it is a different relationship, obviously, than an investor. And it's, it's completely different. Yeah, they do come in and they do audit us, we have to report to them on a quarterly basis on how we're doing and how we're achieving our objectives and our goals.

Nick Jikomes 49:34

I see. So there's like checkpoints built in, in terms of, if you get like, I mean, do they get to you all at once, are there different tranches of money and like, as long as you're sort of hitting, hitting your goals, it keeps coming in?

Christopher Weikart 49:45

Yeah, there's milestones that you have to achieve. And of course, there's a lot of oversight from the government to make sure that those are being met. So we we meet them regularly and and obviously address any concerns that are that are needed to be to be ironed out. And then yeah, the money comes in, in increments. And, and of course, as it comes in we we just continually focus on expanding our capacity as he said, you know, going from $10 million a year to 10 million files a month is a huge expansion effort. So it requires not just capital buildings, but people I mean, went from literally 200 to, you know, basically doubled. Our our folks here at our Auburn Alabama facility, which, you know, is is a feat unto itself in and certainly less than less than six months that we did that. How big is the facility? Yeah, our manufacturing facilities, about 300,000 square feet, that includes obviously office space, but the majority of that is manufacturing space. These are clean rooms, that maintain, as he said, a sterile but clean environment for all the all the products that we make very different from a glass manufacturing facility in terms of cleanliness and sterility.

Nick Jikomes 51:13

And is are there any? I don't know, are there any like interesting r&d projects that you can talk about? Anything that, you know, you're not you're not fully building and selling yet, but a new kinds of materials for new kinds of applications?

Christopher Weikart 51:25

Yeah, no, absolutely. We're certainly focused in quite a few different areas, couple of which I could comment on would be on the cell and gene therapy markets, these are, this is an emerging area very exciting, selling gene therapies to address them for really tough diseases that are that are out there. These a lot of these are obviously going through clinical trials today. These particular class of biologics has very cold temperature requirements, some down as low as minus 180 degrees Celsius, that's very, very cold, that's like minus 320 degrees Fahrenheit. So I am, but again, because they're so sensitive, they require storage at those temperatures are our packaging being a great candidate for those types of packaging. So we've been heavily invested and, and working with customers developing these new therapies. Also, in the the area of freeze dried drugs, a lot of times, drugs are freeze dried, again, because they're just not stable at room temperature or even frozen. This is a freeze dried process where you freeze it, but you remove all the moisture that's in the product, very different than just freezing it, again, all about just preserving stability. And actually, some of the some of the drugs, or the vaccine makers like Maderna, and Pfizer are looking at ways of freeze drying their vaccines to preserve it for longer periods of time. So we have a line of vials that are ideal for freeze drying drugs. And we've been promoting that as well. So those are just a couple of the areas that we've been focusing our efforts on.

Nick Jikomes 53:20

Interesting. Do you have any recommendations on any resources or sort of general areas that people would look into if they were interested in studying material science or getting started in that direction?

Christopher Weikart 53:34

Yeah, yeah, certainly, there's a number of different as I said, universities that specialize in this, I'm not gonna I'm not gonna mention those by name. But I mean, I certainly you can get on the line and find, you know, universities that specialize in material science and engineering as as a as a field of discipline. There are certainly in a lot of journals, some of which we publish in. We do publish, certainly in through parenteral Drug Association. Now, this is specifically for drug products, including liquid injectables and biologics. But there's a lot of material science that are brought to bear in the packaging area. And so we publish in that area. Journal of Pharmaceutical Sciences is another area, we're obviously focusing on on the the fields of science that are specific to drug products, but certainly a lot of material science articles that are in those journals. And, you know, I think if, if you come to visit our facility, you'll you'll get a certain lesson material science. We do offer tours here and be happy to entertain folks that like to see our facilities and understand our products and how we leverage material science to make our products.

Nick Jikomes 54:53

Interesting. Well, this is a fascinating area that I didn't expect to actually learn this much about, but it's obviously very important given, given the times that we're in, is there anything else you want to speak about? Before I let you go, Chris, that has to do with what you guys are doing with respect to these vials.

Christopher Weikart 55:10

Now, it's really, really a pleasure to share about what we're doing as a company and some of the new things that we're working on. But as I said, right now is our main attention is on the vaccine for COVID. And, but at the same time, you know, addressing a lot of new drug products that are coming through the pipeline, and I just, you know, biological sciences, and these new drugs, certainly require of expertise. But I've certainly learned a lot over the 10 years I've been here. And I think if I had done it all over again, I probably would have focused on on molecular engineering of some of these drug molecules, it's just so incredible. The diseases that one can treat these days, and I think, you know, it's some point, you're gonna see a lot of these common diseases and disappear and or at least be able to be treatable, so people can live their lives in a more normal way. So I'm just so excited to be a part of that, that path, and providing the packaging that can enable some of these new drugs into the marketplace.

Nick Jikomes 56:22

Interesting. Yeah, it's fascinating stuff. Do you guys have like a website? Are there any like YouTube videos up that that people can go to to learn more about how all this stuff works?

Christopher Weikart 56:33

Yeah, yeah, you can go to our website, from the asset to Material Science website. And then we do have a number of YouTube videos that you can find on both our website as well as on LinkedIn, you'll see videos, not just a manufacturing process, but how we make our products and a number of videos of our employees of our management explaining what we're all about and what we do and again, some of the advantages of our products. So yeah, I would say you know, LinkedIn, as well as our, our company webpage can explain a lot

Nick Jikomes 57:13

of that. Alright, well, I will link to some of that stuff in the show notes for people who are interested, interested in checking it out. But Chris Weicker, Thanks for walking us through all this. Thanks for your time.

Christopher Weikart 57:23

Thanks, Nick is absolute pleasure.


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