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Fill-Finish Podcast 1: “Current Trends in Isolation Technology and Vaccine Production”

Participants

  • Guest: Les Edwards, Vice President of Technology and Business Development, SKAN US
  • Host: Rizwan Chaudhrey

Rizwan Chaudhrey: Hi everybody, this is Rizwan Chaudhrey, and I’m delighted to be introducing you to the very first Fill-Finish Podcast which has been sponsored by ApiJect. This show aims to share expertise on all aspects of injectables of vaccines and aseptic fill-finish. In fact, we’re very excited to launch this podcast which is going to be running over 10 episodes this season, to focus on various topics, including facility design, regulatory, quality, supply chain management, and AR/VR to name just a few. Today I’m very delighted to introduce our very first guest, Les Edwards, Vice President of Technology and Business Development at SKAN US. And he’s going to be talking about current trends in isolation technology and vaccine production. So, Les, first of all, it’s lovely to meet you and welcome to the show. Thank you for being our very first guest.

Les Edwards: Oh, thanks for having me, I’m very excited to be part of it.

Rizwan Chaudhrey: Well, Les before we start talking about “Current Trends in Isolation Technology and Vaccine Production” would you mind giving viewers who are not familiar with SKAN US a little bit about the company and also your own background?

Les Edwards: Yes, sure. I’ll start off with myself. I’ve been with SKAN US for the last 11 years. As you mentioned
I’m the Vice President of Technology and Business Development, but what that really means is that I’m in charge of making sure that the products get applied to what they need to be applied to for our customers and we have a better process understanding of how they’re being used. We’re always trying to build our service organization and try to help our customers better utilize our products. Of course, we want to develop the technology as well as get faster, better, stronger as a company, but that’s kind of what we do, or what my role is at SKAN US.

Les Edwards: We’re the global leader in isolation technology for aseptic isolators. So, it’s very timely that we’re talking about vaccine manufacturing here because we believe, through estimates anyhow, that about one out of three vaccines in the world are actually manufactured in SKAN isolators, so it’s interesting that that we get a chance to talk about vaccine manufacturing in this day.

Rizwan Chaudhrey: Brilliant. And Les you just said that there’s obviously no one better to talk about the current trends than you! So, let’s start with the very first question, which is, What do you see as the main drivers for isolation technology for vaccine manufacturing within the last 2 to 5 years?

Les Edwards: It started off, there was a transition going from conventional clean room technology into using other barrier type systems like RABS and other things, to improve quality. And then isolation technology has really become kind of the de facto standard for first class manufacturing, It’s the gold standard now for aseptic manufacturing. Of course, today the main drivers are capacity and flexibility.

Rizwan Chaudhrey: And is there an identifiable trend in the type of fitting lines customers are asking you to design?

Les Edwards: It’s going in two different directions. There’s a lot of small-scale manufacturing that was occurring and the trend was going definitely going that way with cell and gene therapy and a lot of customized personalized medicines. But at the same time COVID happened, so there was a boom in we need billions of doses as quickly as possible, so capacity ended up taking over again. Kind of the old-fashioned way of getting more product out as quickly as possible.

Rizwan Chaudhrey: Well, you mentioned COVID. How has that impacted biopharma companies’ needs and behaviors? Are they still seeking speciality custom design lines or are they focused on short delivery time?

Les Edwards: Both! But still it’s been interesting, we have two different kinds of types of clients, we still have the big pharma clients who want to customize and turn it into their system,. We also have a lot of contract manufacturing people who are utilizing the more advanced isolation technology that want to take a good, solid design and make a turnout product as quickly as possible. So, if I had to pick one over the other, I would say that because of COVID people are taking more standard design lines, and they want capacity and they want it quickly and they want to deploy that capital and deploy that capacity as early as possible.

Rizwan Chaudhrey: Obviously, because of COVID there’s been extensive travel restrictions. How has that impacted how you design and validate filing equipment?

Les Edwards: Designing and building is one thing and, going back to the previous question, standard is better, standard is faster. What you have done before we know what is going to work. But when we know it is going to work, delivering the equipment is only half of the battle. We have to get the equipment up and running, we need to train operators, we need to get the system qualified, get regulatory approval, things like that. A lot of those things are on fast track as well, so we need to deploy resources. With the travel restrictions there are even more challenges because SKAN as an organization, is based in Switzerland. Like a lot of other European manufacturers of a lot of the distilling equipment and isolation technology equipment we needed to be able to respond within the borders of the United States to be able to start-up, qualify, and test all this equipment. We could not fly people over from Switzerland all the time to do all the “hard work”, so we had to really build our infrastructure in the United States to be able to do that, we were planning to do it anyhow. Les Edwards: COVID gave us a gentle nudge in that direction. Our five-year plan was accelerated to let’s do it next month, those types of acceleration patterns. We also did a lot of new technologies, where we did remote FATs with a lot of people. We used VR goggles and webcams and people tolerated things that they would never tolerate before, in terms of both standardization and also how they tested and accepted equipment, because they had to. We found that it worked, you can do business remotely. Our sales have grown tremendously over this time as have a lot of filling line manufacturers and things. But you would think that there will be a contraction in the industry because our salespeople have not been able to go out and see customers. It turns out that is not necessary in the middle of a pandemic. Especially when you are trying to give medicine to those who are suffering from it.

Rizwan Chaudhrey: So, Les, you mentioned about virtual reality, do you think these new forms of digital support my here to stay and also how do you think that it impacts vaccine manufacturers in the next 2-5 years?

Les Edwards: It’s a great question. We deployed these tools here because, again, we had to. We had to use them in order to utilize mockups originally. In the design phase, we would use 3D modeling and advanced tools to be able to utilize the engineering design. But then we did them during factory acceptance testing. Now we are actually using them in service as well. We use them in the startup and qualification, the equipment, and the ongoing maintenance. If you sign up for 24/7 service with our company, you get a set of AR goggles and we have that as a virtual support system, so we can see what you’re seeing and really help the customer. It gets us working more closely with the customer, again, because we have a tool that we were forced to use and now we’ve realized the benefit, so yes, absolutely.

Rizwan Chaudhrey: I think it has an impact on sustainability as well, doesn’t it? I think with all these companies looking ahead to seeing how they can become sustainable. The whole virtual reality and digitalized aspects of the service making that you can do things remotely as you say and makes it sustainable overall as a business.

Les Edwards: Absolutely our customers are demanding it, our investors, as a public health company, they want us to lower our CO2 footprint and certainly reducing intercontinental travel as one of our cost saving measures actually is a planet saving measure as well.

Rizwan Chaudhrey: Right. Now what do you expect for vaccine manufacturers the next 2-5 years? Do you expect the contraction in need for future capacity or continued expansion?

Les Edwards: There’s two things going on. To be honest, I think there’s going to be a bit of a glut of capacity as people are still buying lines now. But COVID is a great example of corona type viruses. They mutate very easily and they’re a moving target similar to flu. The flu vaccine changes every year, we need to reformulate it. Maybe be the same thing for COVID type vaccines. There’s going to be more of a need for vaccinations, but also vaccine technology in general. Not just for infectious diseases but also for fighting cancers and things like that. A new way of formulating drug product and a new way to attack disease is having your own immune system build its own defenses against it and we use vaccine style technology but we’re also using cell and gene therapy. A lot of that “stuff” ends up being very small-scale, so I do see the large-scale broad products. We probably will have a little excess capacity in the end, but there’s going to be a transition into small-scale as well.

Rizwan Chaudhrey: How has backseat manufacturing technology impacted your future plans to provide solutions for customers?

Les Edwards: Typically, we are building on two tracks, we have two different plants that are separated. We have the small-scale modular: build it fast, build it based on known designs and get stuff out there that can be used for small-scale lines. Then we have the ability to can flex over and build more capacity for large-scale, if there is another pandemic or another something else coming down the line, I don’t think it’s going to be 100 years for the next one will be 5 years, maybe it’ll be 10 years or 20 years. We need to be able to respond to it. A lot of governments want to build that capacity within their countries. You see a lot of political impacts of how the United States and Europe as wealthier countries were able to build their own vaccine capacity. But was that fair to the rest of the world, and it becomes a matter of self-preservation as well. If a virus is able to mutate in the rest of the world and propagate it is in the first world countries own best interest to have good manufacturing capacity and spread that around the rest of the world, so it’s a rather dramatic political awakening that happened at the same time as this this pandemic.

Rizwan Chaudhrey: Yeah, a 100% agree. So, do you see a relationship then between cell and gene therapy innovations and recent vaccine technology?

Les Edwards: I think, as I was saying, a little bit earlier, I touched on, the cell and gene therapy is getting closer and closer to the patient That’s going to be used more for genetic diseases, preventing disease, and also curing things like various cancers and the like. I see vaccine manufacturing being just one slice of that cell and gene world. II also see the large-scale manufacturing for large populations needing to get done and there’s going to be a lot of capacity and higher quality capacity, more mobile capacity in the future, so you want to be able to do localized manufacturing. Working with companies that are non-governmental agencies in second world and third World countries to be able to build capacity is going to be a huge change in the industry. It’s going to require a lot of these same technologies to be utilized but also be simplified and more turnkey generated so it’s easy to build capacity very quickly.

Rizwan Chaudhrey: So, Les that’s really great what you just said to me. One question I do have to ask you, though, is that one huge topic within the industry. Supply chain and the impact it’s having on pharma. How have supply chain issues impacted SKAN and your customers and how have you overcome those? Looking ahead, do you think they’re here to stay, or do you think we’ll be able to resolve them going forward?

Les Edwards: Very interesting question, very timely question. We are in the midst of a recovery from a pandemic and a recovery from a global recession. While we’re doing that, we’re trying to work through lots of supply chain issues. The initial thoughts people have is, what about computer chips, what about the cost of stainless steel. All of those things have gone up in cost and chips are tough to come by. You might think, wow, an isolator doesn’t use that many chips, but it does. We have small chips embedded in our air handling systems. Just in the fan filter unit and that one small item can throw off the delivery of an entire large-scale isolator system. We have our HMIs, computer-based human machine interfaces, that are required to run all of this equipment and then you get to the logistics of just shipping this equipment overseas.

Les Edwards: We have a global manufacturing platform where we manufacture different parts of different equipment in different countries and the cost of shipping stuff from one place to the other was kind of well within our grasp. During COVID, sometimes our logistics costs, they didn’t go up 25-30%. They doubled, tripled, sometimes went up five times. It was a dramatic challenge for us to not only get product to our customers, but also handle the cost implications of that in the context of something that was focused fixed price and well known. You can handle small variances, but when stuff triples and quadruples overnight it really makes a challenge.

Les Edwards: So, we work through it, like everybody else. I have to say our customers in the pharmaceutical industry were very understanding and they got into problem solving mode with us. They worked with us side by side, to make sure they got deeper into our operations and we got deeper into theirs to help understand each other better, so we could solve some of these problems.

Rizwan Chaudhrey: Brilliant. Thanks, Les. One other question because you just answered about chips. It struck me how much AI or machine learning now being incorporated into the fill-finish process? Is it something which has been incorporated or is it something you see developing more in the future?

Les Edwards: It’s definitely something that’s coming out in our next generation, but I would say right now it’s not a huge impact, but it’s about to be. We have more robotics, more personalized medicine type systems, more intelligent systems. We’re looking at predictive maintenance and a lot of other systems that all involve, not just artificial intelligence, but also more interaction and interface with purchasing systems and building management systems and things like that. Where it used to be some data connected, now when they want real time responses, they want to use that data in a smart sort of way. To help get more efficiency for their filling lines, higher quality, and monitor quality for every single bit of product that goes out. Even vial by vial. All of this is definitely coming in the next five to 10 years and it’s going to hit you like a ton of bricks if you’re not already working at it.

Rizwan Chaudhrey: Brilliant, thank you very much for that. Thank you.

Rizwan Chaudhrey: Well, Les, I really appreciate you coming to take the time to talk to me on our very first episode of Fill-Finish. It’s been really interesting learning more about the topic from you, so, if you would like to learn more about SKAN and the different technologies that you offer around isolation technology, where can I get more information?

Les Edwards: Easiest way is to go on our website at www.SKAN.com and that’s SKAN with a SKAN. I look forward to anyone visiting there. Reach out to anyone around the world from our global sales group and they’re happy to talk to you about our products.

Rizwan Chaudhrey: Fantastic Thank you very much. So there you go listeners, I hope you found that useful. If you’d like to learn more, as I said, you can check out the SKAN website, which is, skan.com/en If you want to speak in English or obviously you can do it in German as well. Les, thank you very much for listening. And thank you listeners for listening to this and I look forward to speaking to you next time. Until next time, stay well. Bye bye.


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