November 10, 2022

By: List Labs

This interview between Jessica Thompson from Kisaco Research and Stacy Burns-Guydish, PhD, President of List Labs, talks about the growth of the Microbiome field for Microbiome CDMOs and digs deep into the Live Biotherapeutics side of this burgeoning industry.

To get further insight into the future of the Microbiome field, check out the video below:

 

Jessica Thompson (Kisaco Research)

Hi, and welcome to the latest of our interview spotlights in the run-up to Microbiome Connect USA. My name is Jessica Thompson. I’m the Portfolio Director of the Life Sciences and Microbiome Portfolio for Kisaco Research. And it’s a pleasure to be joined by Stacy Burns- Guydish, who is the president at List Labs. Stacy, thank you so much for joining.

Stacy Burns-Guydish, PhD, President (List Labs)

Well, thanks for having me.

Jessica Thompson (Kisaco Research)

So to start off Perhaps, it would be great if you could give a little bit of an introduction about yourself and your background in the space.

Stacy Burns-Guydish, PhD, President (List Labs)

Yeah, so I’m the president of List Labs and my background is in microbiology. I got my PhD at Baylor College of Medicine and then did my postdoc at Stanford. A lot of my early microbiome career was focused on more on infectious disease of bacteria and that host-pathogen interaction. Before I joined List Labs, I joined a startup company that was using a strict anaerobic clostridium organism to make a biofuel or a biochemical. So, we improved this organism for making that biochemical, and we scaled the fermentation process up to 100,000 liters. So, this was a really good experience that I brought to List labs and working with strict anaerobes and that scale-up of that fermentation and immediately applied it to Live Biotherapeutic Products (LBPs) and that process development. So, since I’ve been at List Labs now for over six years, I’ve been involved with many of the LBP companies and moving their products to clinical trials.

Jessica Thompson (Kisaco Research)

Great. and what excites you about working in microbiome research

Stacy Burns-Guydish, PhD, President (List Labs)

So, I’m going back a little bit in my history. When I was in high school, in my first biology class the first time, I looked under a microscope, and I was hooked. I knew that I wanted to be a microbiologist, and I knew that I wanted to do something that would benefit society. But I think what I didn’t realize then is how beneficial those organisms in the microbiome could be to our health. You know, bacteria tended to get a bad rap. They’ve always been thought of as ones that cause infection, but they are important to our health. The research in the Microbiome field is revealing all these important synergies that these bacteria serve in our bodies. So, they helped develop our immune and endocrine systems. They help us digest our food, they provide vitamins and nutrients, and they also prevent and protect us from infection. So, it’s exciting to watch the growth in this field from more uncharacterized donor derived products. And now we’re seeing more characterized single organisms or a consortium of bacteria that are being used as a therapeutic to improve patient lives. The field is also evolving from there. So, we’re seeing engineered organisms that can deliver a therapeutic to a specific site. Also, we’re seeing you know a kill switch inserted into the organism, so they provide their function and then they’re eliminated. Then we’re also seeing companies go on to identify the metabolites and the proteins that are also derived from this microbiome associated bacteria.

Jessica Thompson (Kisaco Research)

Yeah, I think it’s an exciting field so far. There’s been so many developments in the field over the past few years for this. Given all the excitement, there’s still obviously a lot of challenges to overcome within the space. What do you think are some of the major challenges that are facing the LBP industry or the microbiome industry more broadly?

Stacy Burns-Guydish, PhD, President (List Labs)

I think there’s two major challenges for me, one is that you know this is a unique product, this LBP Live bacterial organism. So that organism’s viability needs to be maintained through the whole entire manufacturing process. So, this can be a hurdle for some organisms that are difficult to grow. You know these strict anaerobes that oxygen is toxic to them, right? It impacts their viability, and this becomes even more of an issue as you scale up these organisms. It’s one of the reasons why you know people want to probably partner with a Contract Development Manufacturing Organization (CDMO). CDMOs understand what those hurdles are, they know about what you’re going to encounter as you scale up these organisms. So, they can help you optimize that process and knows how to overcome those hurdles as part of the scale up.

I think the second the biggest challenge in the industry is the investment arena. They’re being cautious. There’s no commercial product approved yet, so everyone’s waiting for that BLA approval from you know either fairing or series. And then once that happens, I think that’s really going to drive the field forward.

Jessica Thompson (Kisaco Research)

Yeah, I would agree for sure. And turn into List Labs a little bit more. So, if you’re going to hear a bit about what your company sort of focus in the space your expertise is and how you’re hoping to help overcome those challenges really.

Stacy Burns-Guydish, PhD, President (List Labs)

List Labs was started in 1978. So, we have over 40 years of experience with bacteria. We started with bacterial-derived products. And we have over 100 products in our catalog of high-quality reagent-grade products used in medical research and vaccine development. We also have the experience that we designed and built our facility specifically for containment and segregation to be able to do GMP manufacturing. Also, it was designed for the use of spore formers. So, we have a long history of working with all different kinds of organisms. Strict anaerobes, aerobic organisms, and spore formers. We also have the experience performing GMP manufacturing for many different companies that have gone on to late-stage clinical phase and who now have commercial products.

So, you know, we have quite a bit of history of moving companies through their clinical phase to success to commercial. So, with all this experience that we have, it fits well with the microbiome space. Because we have experience with all those different organisms, we are one of the first companies to produce and manufacture a live biotherapeutic that went into clinical trials. Since then, we’ve manufactured dozens of LBPs that have gone into clinical trials. We’ve also just recently installed a 500-liter fermenter here at our facility. So, we can continue to support companies through their phase 2 manufacturing when they need larger capacity.

Jessica Thompson (Kisaco Research)

And, of course, you partnered with genome and company last year to further your capabilities even further than that. Can you speak to what motivated this partnership and how you’re hoping it will be beneficial over the coming years?

Stacy Burns-Guydish, PhD, President (List Labs)

Yeah. So, List Labs here at the California facility has served customers for Phase 1 and Phase 2 manufacturing, but we aspired to provide our customers with an end-to-end solution. We also saw that there was an opportunity that there wasn’t a lot of capacity in the market for commercial LBP Manufacturing. Genome And Company also had a large pipeline of LBPs that they also wanted to secure their early and late phase manufacturing for. So, this was really a very synergistic relationship with List Labs and Genome And Company. List Labs had the expertise we’d manufactured LBPs and have GMP experience. We have experience designing our own facility, while Genome And Company have very interested investors that are ready to build a new facility for commercial manufacturing.

Jessica Thompson (Kisaco Research)

It sounds like it will be a really exciting development to watch. And with that. And just for this lab, I suppose as well, what are your ambitions then for the next 5, 10 years? What are you hoping for in terms of your next steps?

Stacy Burns-Guydish, PhD, President (List Labs)

You know, so it’s all about supporting our customers that ended in a solution. So, we’re planning to build a new facility in fishers, Indiana, for Phase 3 and commercial manufacturing. That facility is going to be 130,000 square feet specifically for LBPs. It will have four manufacturing lines, and it will be able to accommodate all different types of organisms, from aerobes to strict anaerobes and spore formers.

The production lines will include a 2000-liter fermenter and it will either be stainless steel or single use type fermenter to provide flexibility for our customers. We’re also going to have the ability to formulate and fill in a strict anaerobic environment which we really believe is a differentiator for us. In this facility, we also have QC laboratories, office space, and GMP warehouse space as well. And our ambitions are to expand from there. You know, we want to have sites around the world and we see ourselves as a global Microbiome CDMO company.

Jessica Thompson (Kisaco Research)

I’ll be watching this space then to see where you’re emerging over the next few years. So, we’re really excited to be welcoming you as a platinum sponsor at Microbiome Connect next month in Boston. What are you looking forward to about attending the conference?

Stacy Burns-Guydish, PhD, President (List Labs)

List Labs is super excited about being a part of this conference and to support and advance the microbiome field. I’m really looking forward to the amazing agenda that Kisaco Research has put together. I’m looking forward to hearing updates regarding emerging therapeutics and specifically about Microbiome derived metabolites that might be used in autism as a therapy.

We’re also excited to hear about gut microbiome candidates that improve the efficacy of checkpoint inhibitors for cancer. Also, how companies are advancing their process strategies, such as co-culturing for consortium organisms and single-use alternatives as well. We’re going to hear about engineered organisms for specific delivery of a therapeutic to a site and also great talks from regulatory and quality representatives as well.

So, I think this conference is going to be excellent, not just for a seasoned microbiome veteran but also for those new scientists and innovators that are coming into the field.

Jessica Thompson (Kisaco Research)

Yeah, it was a real pleasure putting together the program this year. There’s so much exciting work that’s being done in the space. It’s almost too much to choose from in terms of when it comes to putting together the talks, and obviously, you’re going to be presenting as part of our bio-processing strategies track as well as chairing that track of the conference in terms of your presentation. Can you give us a quick snippet for the audience in terms of the key takeaways you’re hoping they’ll get from your presentation?

Stacy Burns-Guydish, PhD, President (List Labs)

So, I think we’re going to do something a little bit different than what other CDMOs have previously done. You know, you’re going to get to hear a success story from one of our actual clients, Sciota Biosciences. They have a groundbreaking phase one clinical trial that they’ve just completed using a unique activated bacterial therapeutic for autism. We worked alongside Sciota to develop their process and specifically to develop and manufacture a unique vehicle that’s a part of their drug product. This project was truly a partnership, and I think it’s a great example of List Lab’s ability to be a partner. We’re transparent, and we want to drive to innovate, solve problems and provide solutions.

Stacy Burns-Guydish, PhD, President (List Labs)

Sciota’s story is inspirational, and it’s really going to tug on your heartstrings a little bit. But, I think it enforces, at least, what motivates me, and I think others and their passion for advancing LBP therapies for a healthier world.

Jessica Thompson (Kisaco Research)

Great, well, I definitely look forward to listening, and I think it’s going to be a great addition to the program. So, thanks so much for taking the time to talk to me. It’s great to hear a little bit more about List Labs, and I look forward to seeing what you guys all do in the future. Thanks so much.

Stacy Burns-Guydish, PhD, President (List Labs)

Thank you so much for your time