Innovative Lab Spaces and Cleanrooms on Demand with Azzur Group's Ravi Samavedam

In this episode of "From Lab to Launch" by Qualio, Meg welcomes Ravi Samavedam, the Chief Innovation Officer of Azzur Group. With over two decades of experience as a seasoned biochemical engineer, Ravi is a driving force behind Azzur's groundbreaking approach to lab spaces and cleanrooms.

Discussion Highlights:
Ravi delves into Azzur Group's evolution since its formation in 2010, emphasizing its roots in equipment and facilities for the biopharma industry. The conversation unfolds with a focus on Azzur's revolutionary "Cleanrooms on Demand" concept, drawing parallels to Legos for its flexibility and efficiency. Ravi explains the benefits of licensing lab space, offering a hybrid model that accelerates time-to-market for biotech and pharma companies.

The conversation explores how Azzur ensures GMP compliance in multiproduct facilities, emphasizing quality systems and strict agreements. Ravi elaborates on Azzur's one-stop-shop approach, providing a range of services under one roof, from testing labs to consulting. The discussion touches on the lab space shortage, both pre- and post-COVID, and the potential implications for the industry.

Ravi shares insights into emerging trends, expressing particular excitement for the potential decentralization of cell therapy manufacturing near hospitals. The episode concludes on a lighter note as Ravi reveals his personal interest in geography.

Connect and Learn More:
For those intrigued by Azzur Group's innovative solutions, virtual facility tours and more content can be found on their YouTube channel. Additionally, the Azzur website offers a wealth of information, including recent articles and client testimonials. Listeners are encouraged to explore further at Azzur Group's Website and YouTube Channel.

This episode provides a comprehensive understanding of Azzur Group's transformative contributions to the biotech and pharma sectors, offering a glimpse into the future of flexible and efficient lab spaces.

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https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

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Music by keldez

Transcript

Meg Sinclair: 0:23

Hi everyone and thanks for tuning in to From Lab to Launch by Qualio. I'm Meg, your host. Glad to be here and really excited for today's episode. Before we get started, we'd love it if you rated the podcast. It's easy to do and share it with any of your science nerd friends. We know you've got some. If you'd like to be on the show, please see the show notes for an application. And if you like Legos, then today's show will be interesting to you. We're welcoming Ravi Samavedam, Chief Innovation Officer of Azzur Group. Ravi is a seasoned biomedical engineer. Ravi is a seasoned biochemical engineer with over two decades of experience in the biotech and pharma industries. He's an expert in phase appropriate cGMP implementation, process validation, and supplier management. Azzur helps companies reach the clinic faster and create therapies to combat disease by licensing lab space that works like Legos. Their labs are configurable to individual company needs and easily changeable from company to company with zero demolition. Under Ravi's leadership, Azzur helps companies tackle the challenges that fast growing biotechs face, succeed in their business goals, and develop treatments for patients. You can read more about Ravi and Azzur in the show notes. Let's get to it, and welcome to From Lab to Launch, Ravi.

Ravi Samavedam: 1:55

Thank you, Meg. Thank you for the opportunity.

Meg Sinclair: 1:58

Well, to start us off, can you tell us more about what Azzur group does and what brought you to your role there?

Ravi Samavedam: 2:04

Sure, the name Azzur has been around since 2010. It was formed as a merger between 2 companies, which at that time was serving the biopharma industry, primarily doing equipment and facilities related work. Engineering validation quality work mostly around the processes, um, whether it be facility startups or new product introductions and so on. And then over the years, since 2010, we've added on other, uh, services into our portfolio, including labs that do testing, not to be confused with our clean rooms on demand. business, which is relatively new. And then we still continue to do consulting. That's, uh, I'd say about 50 percent of our employees are in consulting. And then we also have a training division in North Carolina that provides CGMP training to, to, uh, startups, to, um, operating companies who don't want to disrupt their own clean rooms for CGMP training. So yeah, we have four verticals. Uh, I've been with the company since 2012. And clean rooms on demand is, uh, one of the divisions that started in 2017. And I was one of the founders of that division.

Meg Sinclair: 3:15

Very interesting. Um, so the lab space is often compared to Legos in terms of flexibility at Azzur. Um, can you share exactly how that works and how it works like Legos?

Ravi Samavedam: 3:27

Sure. So under our clean rooms on demand offering, we provide clean rooms and related CGMP services really enables our clients to get to the clinic faster and then eventually get to commercial faster. And the way we do that is we build these, um, we take the shell warehouse buildings and build out the CGMP compliant infrastructure amenable for. manufacturing, which includes panel based construction of clean rooms that are very flexible, meaning you can expand pretty easily compared to a stick built clean room facility. You can connect clean rooms. Um, so there's a lot of flexibility in the design that we build in. Um, so yeah, Legos would be oversimplifying it, but conceptually it's very similar in the sense that, you know, they kind of fit with each other and they. You know, the support structures are very, very quick. It takes a long time to design, order, get it built, but in terms of the actual installation, it's very, very quick.

Meg Sinclair: 4:36

Very interesting. I love that modular approach that you're taking. That's really innovative. Um, so licensing lab space is a novel concept. Could you elaborate on the benefit it provides to biotech and pharma clients and how it differs from more traditional models of facility

4:52

utilization?

Ravi Samavedam: 4:53

Sure. You know, traditional biomanufacturing habits in two ways. You know, traditionally it's happened in two ways. The first way is you go build your own infrastructure. You hire a lot of people, you build all the quality systems and you execute your process and you make batches, right? That's completely in your control. It's very capital heavy. You have to build a facility and it's very time consuming as well, requires a lot of expertise. The second option is you outsource your process, your product to a third party, such as a CDM That requires you to share your intellectual property. It is also pretty rare to find the expertise that you need exactly at the time that you need. So you may have to wait there as well. There's a tech transfer that needs to happen of your process to that third party, which has potential of failures. Uh, when you need to make process changes, which is critical, especially early on in the product life cycle again, you have to, uh, retrain the third party to make sure that those changes are effective. Um, yeah. So each time you want time in the schedule, you may or may not get it. So, you know, time is against both two biomanufacturing. So we came up with a hybrid model. called clean rooms on demand. They're not just labs. They're actually GMP manufacturing spaces. Although I guess you could use the term labs, but we prefer to, you know, call it manufacturing spaces really. Um, and clients can do any work starting from preclinical early phase clinical. And now we are seeing some of our clients transition into, you know, larger commercial ready, uh, clean room facilities as well.

Meg Sinclair: 6:34

The clean room environment is of the utmost importance for many life science projects. How does Azzur Group ensure that its clean rooms, especially these clean rooms on demand, meet the stringent standards required for various research and development activities for all these different customers that you serve?

Ravi Samavedam: 6:51

Right. So each facility is a multiproduct facility. So there may be multiple clients making products in the same facility. So our responsibility is to take care of the GMP compliance of the entire facility and all the services that we provide, whether it be environmental monitoring, pest control, security, and the list goes on, right? All the materials management that we do for all the clients. So we have our quality systems that are designed for them. You know, by a form of manufacturing. Um, we make sure that we are due to the various regulations that are out there that will be applicable for whatever their clients are making in the facilities. But we also have a pretty strict quality agreement that we put in place with our clients to make sure that the responsibilities are clearly delineated and to make sure that if there's anything specific to the product or process that requires above and beyond what we Uh, you know, uh, provide us on a standard basis. We incorporate that at the outset of the use of the facility. Um, you know, capital conservation is definitely a benefit of this model, but it's really all about time. Right. You know, both the traditional options, you have to wait six, nine months, 12 months, maybe more, you know, especially if you're building, it'll take you two years to build and qualify a GMP facility from scratch. Um, so if the molecule can afford to wait, great. But nine times out of 10, companies are in a conundrum, right? Because you don't want to spend capital too early, because you don't know if the molecule is going to progress, you know, quickly enough to get your ROI, right? But you don't want to be too late because it takes two years to build. So, uh, you know, which is why a majority of, especially cell and gene therapy companies, uh, prefer CDMOs, the, you know, outsourcing approach. But again, that has potential failures as well. So. Um, yeah, we have successfully, you know, had clients come in preclinical and now they're transitioning to later phase clinical. We have examples of that. Um, this model works for startups. It works for C. D. M. O. S. Moderna happens to be one of our biggest clients in one of our facilities in Burlington, Massachusetts. Congratulations. So, yeah, you know, I could go on and on about about the business because it's sort of my baby, but, uh, yeah, please stop me whenever you need to.

Meg Sinclair: 9:09

Yeah, this is, this is fascinating to hear about your clean rooms on demand and the modular approach that you're taking and offering these, um, early life science companies a third option to get to market faster. I think that's awesome. Um, so, you know, thinking about those CDMOs, what sets apart in terms of support and services that you offer to your life science companies.

Ravi Samavedam: 9:32

Yeah. So, you know, with the four pillars of Azzur in terms of services, we're able to provide a one stop shop for clients, right? Whether it be their testing needs through our Azzur Labs division, training, you know, consulting arm provides even process operators if our clients need it. So, yeah, you know, in that, in that respect, we, we've managed to provide a large number of services that any company would need. All, you know, under the same roof. So, you know, reducing the, you know, time for supply chain logistics to happen because it's all happening right there.

Meg Sinclair: 10:07

And you have labs all over the U. S. Correct?

Ravi Samavedam: 10:10

Yeah. So we have, uh, you know, five testing labs as your labs. You know, they do microbiology, chemistry, biochemistry, testing, selling gene therapy, testing for raw materials, intermediate and final products. But then we have six clean rooms on demand facilities, each facility having anywhere between 9 to 30 claims, uh, in the biotech heart beds across the U. S. So I'm You know, the Boston, Cambridge area, San Diego, San Francisco and North Carolina is what we have so far and more to come in the future.

Meg Sinclair: 10:41

More to come. Any international plans, um, to, to expand internationally?

Ravi Samavedam: 10:46

Uh, not yet. I mean, we do have a lot more hotbeds. I don't know if I mentioned North Carolina. We have a facility there as well. But, uh, yeah, hotbeds that we know exist that we haven't been into. Uh, you know, Philadelphia, New Jersey, New York. You know, Texas, Colorado, uh, so there's a fair bit before we need to go, uh, you know, externally, uh, outside of the U S, but that's definitely going to be the conversation sooner rather than later within our company, I think.

Meg Sinclair: 11:17

I've read that there has been a lab space shortage in major biotech hubs like here in Denver. Um, how big is the shortage and what do you see as long term implications for the industry at large if the issue is not resolved?

Ravi Samavedam: 11:31

Sorry, just cut out a little bit, Mike. Repeat that again. Sure.

Meg Sinclair: 11:34

Um, so I've read about lab space shortage in my major biotech hubs, like here in Denver. Um, how big is the shortage and what do you see as long term implications for the industry if it's not resolved?

Ravi Samavedam: 11:47

Yeah, so interesting you say that because, you know, before COVID there was definitely a huge shortage. But due to COVID, there was a lot of building, you know, converting of office spaces into GMP spaces, lab spaces, converting of warehouses into manufacturing spaces. So all of those are actually coming online. A large majority of those are coming online now, right? So If you talk about just right now, there is actually an overcapacity of labs, in my opinion, especially in the Boston Cambridge area and manufacturing space as well. There's a lot of facilities that are vacant, a lot of capacity that's underutilized, but that's also a symptom of the financial slowdown that have That has happened in the last six to nine months, where people are kind of tightening their bells, you know, in a wait and watch mode, so to speak, a lot of funding has dried up in the last six to nine months. So I think it's a temporary thing that's going to just come back to normal. Because again, there's a lot of activity that has happened in cell and gene the years prior to COVID and a lot of funding that has. Uh

Teena Hart: 13:00

oh, did we lose him? Oh no, he's back.

Ravi Samavedam: 13:13

What happened there? Can you guys hear me? Yes, we dropped off the mic. Oh wow, that's never happened before. Where did I drop

Meg Sinclair: 13:22

off? Uh, talking about funding drying up.

Ravi Samavedam: 13:28

Yeah, so especially, um, the excess capacity that we see temporarily here, especially in the Boston Cambridge area, it's also a symptom of the funding having dried up the last six to nine months. A lot of people are just in a wait and watch mode. And, uh, but I think it's temporary because a lot of funds That had come into the industry prior to COVID still needs to be deployed in terms of actual manufacturing, you know, batches and so on. So I think it is just a matter of time that we'll see the same sort of capacity crunch that we saw pre COVID, you know, especially for cell engine. Yeah.

Meg Sinclair: 14:06

So a lag now, but. Anticipate that that'll kind of flip over soon. Interesting. Yeah. Lots of trends to watch kind of post COVID across lots of different industries. So, um, so looking to the future, what emerging trends or technologies in life sciences and the healthcare sectors excite you the most?

Ravi Samavedam: 14:27

So, you know, especially cell therapy, autologous cell therapy. Yeah, that's pretty exciting. And the potential that you can maybe have manufacturing happen next to the hospitals where the patient's blood is being collected. So the genetic manipulation through the manufacturing process happens next door in a facility, maybe even within the hospital, rather than having to ship cross country, getting it shipped back and putting it back in the same patient. You know, if That takes off as a trend. I think that's going to be a game changer. Right? All of a sudden, timelines are cut short into, you know, the development and deployment of the therapy. Uh, yeah. So I'm excited about that. Then that one specific opportunity. I guess it's very, you know, specific to one area of the industry. But, uh, you know, that would sort of decentralize the manufacturing completely, right? The supply chain will be simplified so much more. Right. So I think that may be a game changer, you know, especially for that part of the industry. That's, that's one thing I'm excited about for sure.

Meg Sinclair: 15:27

Yeah, I'm getting genie vibes from you that you want to save time for everyone, save time for businesses, save time for patients, save time, save time for the supply chain. So, um, I like to think of myself as a time and gravity fighter. So, um, I will be watching to see what Azzur does to help save. save time and watching that cell gene therapy, um, to see how we can save time to patients, um, with pain with drugs and. Lifesaving therapies. So exciting. Yeah. Our last question is more of a fun one. We'd love to ask each of our guests if we ran into you at a bookstore or your local library in which section would we find you,

Ravi Samavedam: 16:09

uh, geography for sure.

Meg Sinclair: 16:13

Geography.

Ravi Samavedam: 16:14

You probably find me sitting with an atlas or a map of some sort. For sure.

Meg Sinclair: 16:21

Interesting. Trying to find the quickest way to get from point A to B, I'm sure.

Ravi Samavedam: 16:27

No, I just, I just was a geography buff, you know, ever since childhood. You know, I still take pride in reciting most of the country capitals of the world.

Meg Sinclair: 16:37

Oh, we'll have to save that for another podcast, Ravi.

Ravi Samavedam: 16:40

Right. That should be a game.

Meg Sinclair: 16:42

That will be fun. Um, well, thank you so much for joining us from lab to launch today by Qualio. Where can our listeners go to follow along and connect with you?

Ravi Samavedam: 16:52

Uh, so there's a lot of content on YouTube, including videos about our facilities that are virtual tours that I would recommend people take, uh, that on YouTubes, if you just search our company name, you can always find it on our website. Uh, there's a lot of information on our website, including recent articles, uh, some client testimonials and so on. So, uh, yeah, that's the best place to go.

Meg Sinclair: 17:13

Great. We'll post those in the show notes. Thanks so much again for joining us.

Ravi Samavedam: 17:17

Thank you so much, Meg.