Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell isolation and recovery. It's a field that few are as passionate about and dedicated to improving as much as Andrew and VitaCyte.
Insights from the discussion:
VitaCyte was started to better understand the mechanism by which enzymes work cooperatively to connective tissue and different cells for things like basic cell signaling research, preparing cells for sale, and even clinical therapies like islet transplantation.
VitaCyte’s mission is to make reagents more suitable for and compatible for the cells of interest, and to move the overall field forward in terms of understanding how this process work.
VitaCyte is different than others because they have a fundamental drive to understand how these reagents work, and how they will ultimately contribute to the quality of the cells that are recovered for specific applications.
About Andrew Breite:
Andrew was originally trained as an analytical protein biochemist. His professional roles have focused primarily on purification process optimization, assay development and product development. Andrew now serves as the Dir of Quality Assurance for a purified enzyme reagent product portfolio at VitaCyte. He has served in numerous roles during his more than 10 years at VitaCyte and helped develop the quality management system from the ground up.
About VitaCyte:
VitaCyte’s co-founders, Bob McCarthy and Francis Dwulet, were key contributors to the development of the first commercial, purified collagenase-protease enzyme mixture used to prepare cells for subsequent transplantation. This improved tissue dissociation enzyme reagent contributed to success of the “Edmonton Protocol,” the first report of successful treatment of adult patients with Type 1 Diabetes where 7 of 7 patients were “insulin independent” one year after islet transplantation. Prior to the introduction of this purified enzyme reagent, most laboratories performing this clinical research procedure were spending significant amounts of time qualifying collagenase lots for their effectiveness to isolate human islets. Once a lot was selected, the lot qualification procedure was repeated within a year, often because of the instability of the enzymes in storage.
VitaCyte was initially funded by receiving NIH NIDDK Small Business Innovation Research (SBIR) awards, a state of Indiana 21st Century Fund award, and several state of Indiana SBIR matching awards.
The VitaCyte team’s curiosity about improving the state of cell isolation/recovery leads us to seek new solutions that reflect our mission to manufacture and support product/services that improve customer productivity. We encourage dialogue with our users who, in turn, stimulate us to develop new or improved products; to collaborate with lead users to develop a deeper understanding of how enzymes release cells from the extracellular matrix; and to engage others at scientific meetings to discuss their concerns about using enzyme to recover cells from tissue or after in vitro culture.
Hi, everyone. Welcome to today's show. Before we jump in, just wanted to say that if you want to be a guest on the show from lab to launch in a future episode, go to the show notes and click on the link to the form to apply. We've had a lot of interest lately, and that's great to see. We want to get more innovators and pioneers on the show. All right. So for today, we're really excited to have the opportunity to speak with one of our customers of Qualio Andrew Bright, from VitaCyte. Andrew is the director of quality assurance at VitaCyte and has been with the company for over 14 years. VitaCyte. Has a really great mission. They manufacture high purity tissue, dissociation agents, and cell recovery reagents. VitaCyte was started to better understand the mechanism by which enzymes work cooperatively to connective tissues and different cells. For things like basic cell signaling research, preparing cells for sale. And even clinical therapies like islet transplantation. VitaCyte's mission is to make reagents more suitable for and compatible for the cells of interest and to move the overall field forward in terms of understanding how this process works. So lots of great takeaways from our friend, Andrew, let's just jump right in.
Emily H.:
thank you for joining today, Andrew. We're definitely excited to have you as a guest on our podcast. How are things going
Andrew Breite:
today? Good. We are staying very busy here, so I'm always looking for a way to work opportunities like this and to the into this case. But yeah, we've stayed very busy during this past year despite all the challenges with COVID things continue to happen in the cell and regenerative medicine space. We're staying.
Emily H.:
Yeah, no, that's great. That's exciting. Yeah, it was. I was reading your bio and you're doing some really cool, innovative things. So definitely excited to, to jump in and learn more about you. Awesome. For our first question so would definitely love for you to tell us about your company, the mission how you are changing and shaping the life science.
Andrew Breite:
Okay. Yeah. So if I decided it's a very small company, it was born out of the the desire or the need, to better understand how tissue dissociating enzyme, such as collagenous is work to release cells of biologic interest. The. These types of products have been on the market for many decades, but in the early nineties they were they started to be used for islet aloe transplantation in the variability between batches caused a lot of problems for reliance, for relying on them to make a clinical therapy. So there was some development done at that time. And just some new products were brought to market that partially resolved issues, but still didn't fully address all of these shortcomings in terms of variability, between branches and overall performance. So Vita site was started to better understand the mechanism by which these enzymes. Cooperatively to degrade a connective tissue and release cells from different types of tissue for a variety of different applications. That may be as simple as a basic cell signaling research. It could be for use in actually preparing cells. For to sell sells for sale as it were. And also clinical therapies, like the islet transplantation that I referred to earlier. So we now manufacture highly purified tissue dissociation, or cell release reagents that are designed to better correlate formulation and characteristics with the requirements for different tissue types. Applications. So our mission really is to improve these types of reagents, make them more suitable and compatible for the cells that are being of particular interest. And to really for move the field forward in terms of understanding how this process works. We're I think we're changing changing this field in particular, into into ways for were re redesigning how cell recovery reagents are designed and manufactured. Historically there was a lot of variability that I referred to and many users had to screen different, lots to test in their procedure to see if they would work. The user was really at the mercy of the output from the fermentation process. But Vita sites approach is to purify these individual enzymes and then recombine them, reformulate them in the optimal combination for. Connective tissue types. The second is I see us as serving as a resource for all things related to cell isolation. This is a process that is much harder to capture as a kit format that you might see for something like DNA purification and recovery of plasmids. And there's not a lot of information out there. Give users guidance on how to optimize the process for the recovery of cells without damaging the cells of interest. So we see immense value in working closely with users to help correlate those enzyme requirements for their specific success criteria. We like to think of ourselves as serving as a repository of knowledge related to those techniques. So that users can more quickly find a formulation that works. And then once they do ensure that it remains consistent between between batches. And I guess maybe a third element might be our participation in. Conferences and peer reviewed publications. We still think that there's a lot to understand about, of this process. And there are a number of very promising clinical therapies that are dependent on the use of these types of reagents for the cells of interest. And there's a need to ensure that we participate in and do the best science possible for the reagents in the. Very long winded answer, but
Emily H.:
it's really cool. It's, I'm glad that we went through that. That's awesome. So what role does quality and quality assurance play for you all?
Andrew Breite:
I think like many in the life science sector, Vita sites sees quality is very much a core value and a fundamental driver of our processes. I see. Both as a mindset and a tangible output, the tangible output of course is the documents of the quality management system. But I think there's also a philosophy of attention to detail, accountability and really focus on good objective science. This philosophy really comes from having a good core team that all believe and are aligned with the mission of the organization. So Qualio is helping support our quality and quality system by at least addressing that very tangible output of quality. But we've come together as a team and just have agreed that. Element of quality is a primary objective for not only our best interests, but the best interest of the field overall.
Emily H.:
Yeah. That's great. What is your favorite part about being part of Vita site and the company's journey?
Andrew Breite:
Real personal motivation by trying to navigate all of the endless challenges that come from the commercialization path. while I have great respect for, uh, early stage R and D. And the very novel ideas that come from that journey. My personal passion is really in helping enable those technologies to become economically viable and accessible to a broader market. I've had the opportunity to help with the earliest stages of product design and process optimization. All the way through to marketing regulatory support and supply agreements bringing a technology or an idea to a point of broad access is incredibly challenging and things that I would never even have appreciated before going through this journey myself. Part of those challenges are only partly within your control. And while I'm certainly not changing the world, I like to feel that I'm contributing to something even in a very small part to therapies that are showing some real promise for improved quality of life. I also focusing on. Tedious or unglamorous parts of the process that oftentimes don't get the attention that they may be, they may be due simply because it's not exciting as the other elements of the commercialization path, but I like working on that.
Emily H.:
Awesome. And then how is a Vita site different from others?
Andrew Breite:
I think fundamentally the way in which we're different is the drive to better understand the mechanism of tissue dissociation. If you place. If you place regenerative medicine and cell therapy applications in the context of what pharma both drug and biologics have always done, it's been based on that fundamental understanding of what is the mechanism of action. And the problem in this case is there are therapies being built on. A process that is not well understood the way in which the enzymes work is only partially understood in very basic models and having a stronger understanding of how these enzymes work together to release the cells of interest. And more importantly, what kind of an impact they actually have. On the cells that are being released is really critical for the long-term viability of these therapies. So we are working diligently to better understand that process. We do that by supporting basic research in this area. To do that by providing guidance and support for users that are attempting to optimize processes for a very long term plan towards the clinic. And also by improving the characterization tools and the assays that are used for understanding what these different enzymes, how they vary from batch to. Perhaps, or how you characterize batches manufacturing, batches for particular apps applications. I think that, The tools that have historically been used, can be improved upon. And we're working to do that because a collagenous family of enzymes and the associated proteases that contribute to the process. We can benefit from using newer technologies than what have historically been used to characterize these types of reagents. So that's how I see us as being different is. That real fundamental drive to understand how these how these reagents work and how they will ultimately contribute to the quality of the cells that are recovered for whatever the application may be.
Emily H.:
Nice. Awesome. You've mentioned COVID earlier. So did COVID-19 happen impact and it sounded like it did on VitaCyte, so that operations, manufacturing, orders customers.
Andrew Breite:
Yeah, I think like probably nearly everyone COVID did certainly have an impact. In the short term we had to decide how we were going to respond as a very small company. Operations slowed down significantly. It pretty much in line with all other organizations they had just slowed their operations. We did see a revenue drop for a period of time. As other institutions slowed down. When they came back online, we essentially came back online and picked up where things had slowed down. We. Did take advantage of that time, however, to try to address some things that were that had been pushed down the priority list for awhile things that we didn't necessarily have to be in close proximity to do or within the manufacturing area. The implementation of quality, oh, actually was an example of one of those things. The migration to an electronic document management system was completed last summer. And we, There was an opportunity in the schedule to, to make that work. We've encountered some significant supply chain disruptions for materials and ASAP for the ASF tick process. That that we use here things that I never expected to be so challenging to do, especially going into science and I never expected to spend so much energy worrying about resources and. Continuity of resources and timelines. So that has made things very challenging. We have been extremely fortunate that we've been able to migrate through that, or I guess I can't think of the right word, but we've been able to handle that process of relatively unscathed, but it was a reminder of just how. We need to be in order to in turn, be a reliable supplier for the users who are depending on us as well. We've also struggled significantly with our shipping in in career delays, although that is improving significantly. I think it's. Like a lot of things, it's just a ripple effect. That's working through the system and things are improving. And I, I think we'll get to a point where that's a little more predictable, but it's been challenging for sure. Yeah, absolutely.
Emily H.:
I know I've heard that from a lot of our customers. So good to hear the thoughts. That's getting better too. Yeah, often. And then where do you see the company in five to 10 years?
Andrew Breite:
We expect modest but steady growth in the next decade. The modest part of that comes from many of these products are supporting. Regenerative medicine and cell therapy applications that are still very much in early stage clinical development. There are numerous complexities to showing the safety and efficacy of these therapies and the regulatory and reimbursement path is still very much evolving. Not to mention the complexities of manufactured. And logistics for these types of therapies. So for now we're very much serving a niche market, which means growth is. By other measures, probably relatively slow. However, we have been steadily expanding our capabilities and developing more application specific formulations that support a whole variety of different uses many of those sites I've already referred to academic research cell manufacturers some of those are supplying hepatocytes for drug screening, for example mesenchymal stem cells and other tissue types. So we're working. Increase our capabilities expand product lines and be positioned as a reliable supplier for those groups that are working through clinical trial. Be positioned to support them as they approach reaching market. And that's the same for our quality system, as well as we are growing with the needs of users that are approaching the regulatory bodies and getting a number of questions about three agents that they're used. We're learning how to be a better supporter of. Those that are going through that process in learning how to better anticipate what we need to do in our processes to better accommodate the concerns that regulatory agencies may have. So the timeline is it in this field is very long. So you have to have the patience and diligence to see these these things through. But I think we're also extremely well positioned based on the feedback that we get from users in terms of our technical support our reliability of supply and our commitment to really understanding the fundamental questions of the process, which ultimately the regulatory agencies are very keen to understand. So we keep a close pulse on The direction of the regulatory agencies and the the needs of users within this field to, to be successful. I think that's where we're going to be. It's going to be persistence and diligence with steady steady growth and new products.
Emily H.:
That's awesome. Awesome to hear. Great. Those were the questions that I had today. It's been great learning more about you guys and what your mission is and the growth and what you guys are doing is as a company. So again, really wanted to thank you for your time today. And
Andrew Breite:
Yeah. Thank you very much for your interest. It's been, it's nice to have an opportunity to speak to where we see our fit in the fields. We may be a bit different than many of Qualio's other customers. But I think our perspective is unique enough that we can provide some real value in contributing to conversations within this space on how to, how to implement an effective and efficient quality system and to think about where your role is in the market. So thank you as well. Yeah.
Emily H.:
Awesome. Great. Thanks again and hope you have a wonderful