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

On May 14, 2020, a team spanning the University of California San Diego, San Francisco General Hospital, Cook County Health and Hospitals System in Chicago, and Washington University in St. Louis published a milestone study in the New England Journal of Medicine. Cohen et al demonstrated the effectiveness of LACTIN-V, a new Live Biotherapeutic Product (LBP) created by Osel, Inc. for the treatment of bacterial vaginosis (BV).

LACTIN-V is a single-strain, topically-administered LBP containing Lactobacillus crispatus CTV-05, a protective human vaginal bacterium that helps to combat the pathogenic bacteria and dysbiosis observed in recurrent BV and urinary tract infections. Its success marks the first single-strain LBP to show clinically significant efficacy in a randomized, double-blind, placebo-controlled Phase 2b trial in the US.

The study was supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). List Labs is excited by this landmark discovery, by the prospects of this discovery for women’s health around the world, and for further supporting the use of LBPs as a viable therapeutic.  We had a chat with Osel’s Director of Product Development, Tom Parks, to find out more about the project, it’s challenges, and why the product is successful:

What are dysbiosis and BV?

Dysbiosis is a disruption of the human microbiome: the collection of microorganisms, including bacteria, that naturally live on and in our bodies. The full function of the microbiome isn’t fully understood, but dysbiosis is known to be involved in a wide range of skin disorders, intestinal problems and gum diseases, among many others.

Bacterial vaginosis is an ecological disorder of the vaginal microbiota in which hydrogen peroxide-producing lactobacilli are displaced by predominantly anaerobic bacteria (e.g. Prevotella and  Mobiluncus species), Gardnerella vaginalis, and Atopium vaginae. It is the most common vaginal infection worldwide among women of reproductive age, and affects about 30% of women in the US. Treatment usually consists of a course of an antibiotic such as metronidazole lasting about five days. The treatment itself is usually effective, but in about 75% of cases BV returns within a year, often within just a few weeks.

Why is treating BV so challenging?

The tendency of BV to recur is due to failure to re-establish a Lactobacillus-dominated vaginal microbiome. Since the only treatment is another course of metronidazole or a similar antibiotic, this can lead to a cycle of re-infection. In addition to the discomfort and negative impact on the quality of life, BV is a risk factor for a wide range of sexually transmitted infections, including HIV/AIDS. It is also a risk factor for premature birth and other reproductive health complications.

Currently there is no approved treatment to prevent the recurrence of BV. Women have tried a range of home remedies, from yogurt to tea tree oil. As might be expected, these are often ineffective, and may have side effects of their own.

Osel has developed a treatment for BV that breaks the cycle of dysbiosis. LACTIN-V is a live biotherapeutic product (LBP) containing the hydrogen peroxide-producing strain Lactobacillus crispatus CTV-05, which is a protective member of the native microbiome. Administered after the normal course of antibiotics (once a day for five days, and then twice a week for 10 weeks), LACTIN-V helps to restore the normal vaginal environment and prevent re-emergence of the organisms that cause BV. In the study reported in NEJM, BV recurrence was significantly less in women treated with Lactin-V (30%) compared to the placebo group (45%) (P=0.01).

What goes into manufacturing an LBP?

An LBP is a therapeutic agent based around a live microorganism, intended to restore a balance in the microbiome disrupted by a disease condition. A contract development and manufacturing organization (CDMO) can provide essential expertise for developing an LBP, but finding the right CDMO is tricky since many contract manufacturing organizations do not have experience with maintaining viability of the microorganism through the entire manufacturing process or are flexible for the process nuances of an LBP product. In addition, many organisms of interest as LBPs are anaerobic to some extent (for example, Lactobacillus are facultative anaerobes), and/or spore-forming. Working with such organisms takes special expertise and facilities to provide necessary containment and segregation, maintain viability, maximize yield, and avoid pitfalls.

Osel’s Tom Parks explains, “Relevant live biologic product experience and GMP manufacturing capabilities are obviously important. Flexibility to handle a number of product formats is also helpful. Since the field is relatively new, companies that manufacture LBPs are few and far between.”

Are you looking for a CDMO for your LBP project?  List Labs has 40 years of experience manufacturing bacterial products and many different LBP products for Phase 1 and 2 clinical trials for indications in the gut, skin, vaginal mucosa, and CNS. List Labs has the expertise for handling and cultivating anaerobic bacteria and spore formers.  We are uniquely qualified to provide insight and the flexibility to match the needs and requirements of each individual project, such as filling different product formats.  We are a passionate and dedicated partner who works as an extension of your team to ensure the success of your project.  If you are interested in an LBP project, contact us at sales@listlabs.com

By: Rachel Berlin, Marketing Manager

Microbiome research is uncovering the enormous potential for developing drugs, such a live biotherapeutic products, from the microbiome.  This burgeoning field is the future of medicine.

List Labs is excited and proud to support microbiome research by providing reagents to scientists studying the human microbiome. Below is a list of microbiome research studies that have used List Labs’ research reagents such as Athrax, Pertussis, Cholera and Difficile Toxins.

Pertussis Toxins Used in Microbiome Research:

• Products #180 – Pertussis Toxin from B. pertussis, Lyophilized in Buffer and #181 – Pertussis Toxin from B. pertussis, Lyophilized (Salt-Free) have been used in the study of regulation of autoimmune myocarditis by host responses to the microbiome
• Product #179A – Pertussis Toxin from B. pertussis (in Glycerol) has been used in the study of bidirectional association between the gut micobiota and CNS disease in a biphasic murine model of multiple sclerosis
• Products #180 – Pertussis Toxin from B. pertussis, Lyophilized in Buffer and Product #181 – Pertussis Toxin from B. pertussis, Lyophilized (Salt-Free) were used in the study of CD44 deletion leading to attenuation of experimental autoimmune encephalomyelitis results from alterations in gut microbiome in mice
• Products #180 – Pertussis Toxin from B. pertussis, Lyophilized in Buffer and #181 – Pertussis Toxin from B. pertussis, Lyophilized (Salt-Free) have been used to study the effect of omeprazole on the development of experimental autoimmune encephalomyelitis in C57BL/6J and SJL/J mice
• Products #180 – Pertussis Toxin from B. pertussis, Lyophilized in Buffer and #181 – Pertussis Toxin from B. pertussis, Lyophilized (Salt-Free) have been used to study an intestinal commensal symbiosis factor controls neuroinflammation via TLR2-medicated CD39 signalling
• Products #180 – Pertussis Toxin from B. pertussis, Lyophilized in Buffer and #181 – Pertussis Toxin from B. pertussis, Lyophilized (Salt-Free) have been used to show a commensal bacterial product elicits an modulates migratory capacity of CD39(+) CD4 T regulatory subsets in the suppression of neuroinflammation
• Products #180 – Pertussis Toxin from B. pertussis, Lyophilized in Buffer and #181 – Pertussis Toxin from B. pertussis, Lyophilized (Salt-Free) have been used to show dominant effects on the diet on the microbiome and the local and systemic immune response in mice

Difficile Toxins Used in Microbiome Research: 

• Product #152C – Toxin A from Clostridium difficile and product #155 – Toxin B from Clostridium difficile were used in researching Immunogenicity and protective efficacy of recombinant Clostridium difficile flagellar protein FliC
• Product #152C – Toxin A from Clostridium difficile and product #155 – Toxin B from Clostridium difficile were used in researching an in vitro culture model to study the dynamics of colonic microbiota in Syrian golden hamsters and their susceptibility to infection with Clostridium difficile

Cholera Toxins Used in Microbiome Research: 

• Product #103B Cholera Toxin B Subunit (Choleragenoid) from Vibrio cholerae and product #104 – Cholera Toxin B Subunit (Choleragenoid) from Vibrio cholerae in Low Salt were used to study the immunogenicty and effects on fecal microbiome of an electron-beam inactivated rhodococcus equi vaccine in neonatal foals
• Product #103B Cholera Toxin B Subunit (Choleragenoid) from Vibrio cholerae and product #104 – Cholera Toxin B Subunit (Choleragenoid) from Vibrio cholerae in Low Salt were used to study the effects of administration of live or inactivated virulent Rhodococcus equi and age on the fecal microbiome of neonatal foals
• Product #101 – Cholera Toxin from Vibrio cholerae was used in research finding that parental dietary fat intake alters offspring microbiome and immunity

Anthrax Products

• Product #171 – Anthrax Protective Antigen (PA), Recombinant from B. anthracis was used in research finding that substrate cleavage profiling suggests a distinct function of bacteroides fragilis metalloproteinases (fragilysin and metalloproteinase II) at the microbiome-inflammation-cancer inferface

 

In addition to producing products for microbiome research, List Labs also provides contract GMP manufacturing of live biotherapeutic products for phases 1-3 of clinical trials. For more information on microbiome and live biotherapeutics- check out this blog post or watch our informative video. See how scientists have used our products in their research on our citations page.

Contact us to discuss your next project!

By: Rachel Berlin, Marketing Manager

List Labs is proud to be exhibiting at the Microbiome Drug Develoment Summit 2018 in Boston, MA. The conference will be held at the Boston Seaport World Trade Center from June 20-22. This conference provides access to the latest preclinical, clinical and commercial case studies from the brightest minds in biopharma and academia to turn microbiome discoveries into patient therapies.

Come by our booth and ask us how we can help you develop materials for your clinical trials! Learn about List Labs’ services including Live Biotherapeutic Products. Check out how others have used our products in their microbiome research on our citations page.

Watch our informative video about our Microbiome and Live Biotherapeutic services.

Contact us to schedule a meeting with us at the show to discuss your next project!

By: Rachel Berlin, Marketing Manager

1978 was a great year for scientific advancement – NASA hired the first women astronauts, the first test tube baby was born and List Labs was founded. Linda Shoer, our founder, saw an opportunity when she realized there was a need for a commercial supplier of Cholera Toxin for studies in signal transduction and neuronal track tracing. On May 18, 1978, Linda started something more than a company, she started a family- the List Labs family.

List Labs’ catalog has grown to include over 100 products, which have been used in thousands of scientific research projects over the years. More recently we have added services to our offerings; this trend started in the early 90’s when List Labs manufactured Botulinum Toxin (Botox) for Allergan. Since then our services have expanded to include cGMP grade manufacturing, live biotherapeutics products, scalable process development for fermentation, purification and lyophilization, enhanced QC testing and more! We’ve also added to our team of experts with employees in Microbiology, Production, QC, QA, Sales and Marketing, Shipping, Administration and Finance.

List Labs carries on the values instilled by Linda Shoer and continues to grow our team, our capabilities and experience. We are excited to see what the next 40 years bring!

By: Stacy Burns-Guydish, Ph.D., Senior Director, Production

The terms “Microbiome” and “live biotherapeutics” have been repeated frequently in the last few years in scientific circles. Researchers are understanding more and more about the various microbiomes in the human body and how they affect our overall health. From this research, microorganisms have been identified that may be beneficial to our health and could be used as a therapeutic, otherwise known as a live biotherapeutic products. This article explains an overview of some microbiome and live biotherapeutics basics.

What is Microbiome? 

The human microbiome is the collection of trillions of microbes living in and on the human body. Scientists believe that it plays a role in many basic life processes and are important to our health.  Perturbation of the microbiome has been associated with a growing number of diseases including inflammatory bowel disease, allergies, asthma, autism, and cancer.

What are some different types of human microbiomes? 

Microbiomes are found, for example, in our gut, skin, vagina, and mouth.  Each of these sites have a different consortia of microorganisms.  Beneficial microorganisms have been identified in each of these niches.  Researchers are studying the various human microbiomes to better understand their importance in health and disease.

What is a Live Biotherapeutic Product (LBP)? 

A live biotherapeutic product contains a live microorganism that is used for the prevention, treatment, or cure of a disease or condition. As the characterization of the human microbiome and its link to human health has become better understood, microorganisms have been identified which may have a health benefit.  The use of these microorganisms as a live biotherapeutic product in clinical application shows great promise.  Several clinical trials are underway to evaluate their potential as a therapeutic.

What equipment and facilities are necessary for the production of a Live Biotherapeutic Products?

Many of the microorganisms identified for the manufacture of live biotherapeutic products are obligate or strict anaerobes and spore forming organisms.  These type of organisms present unique challenges to the emerging microbiome therapeutic space.  In particular, many of the microorganisms are anaerobes which cannot be exposed to air and thus expertise is required in handling and cultivating the organism.  Facilities and equipment important for the cGMP manufacturing of these organisms include:

• Biological safety cabinets
• Anaerobic work stations with internal HEPA filtration for aseptic, anaerobic fill capability
• Equipment to scale the process cultivation
• Stainless steel or single use bioreactors
• Closed harvest systems such as tangential flow filtration with hollow fiber membranes
• Semi-automated or automated filling equipment
• Freeze drying equipment, i.e. Lyophilizer
• Homogenization and milling equipment

List Labs is your partner for Live Biotherapeutic Products

List Labs has manufactured several live biotherapeutic products for phase clinical trials. With 40 years of experience, List Labs is distinctly qualified to help you with your next microbiome project and affords the flexibility required to achieve the strictest timelines and goals. We understand that each project is unique and we draw from our vast experience to deliver you a custom solution that meets your needs. Contact us today to find out how we can help you!

 

By: Rachel Berlin, Marketing Manager

List Labs is proud to be exhibiting at the 4th Annual Translational Microbiome Conference April 18-20 at the Boston Marriott Long Wharf.

List Labs has extensive experience with microbiome and more specifically live biotherapeutic projects including vaginal, gut, skin and the central nervous system indication and tumor treatment – many of which have completed Phase I and Phase II trials. Stop by our booth and find out how we can help you with your next microbiome project. Learn about how scientists have used List Labs’ products for their microbiome research on our citations page.

Interested in scheduling a meeting with us during the conference? Contact us!

By: Stacy Burns-Guydish, Ph.D., Senior Director, Microbiology

The human body is home to a vast ecosystem of microbes, called the microbiome.  Research is shedding light on the importance of the microbiome as a benefactor to our health and development.  Perturbation of the microbiome has been associated with a growing number of diseases including inflammatory bowel disease, allergies, asthma, autism, and cancer.

Microbiome Bacteria as Potential Therapy

Commensal bacteria of the microbiome are thought to be potential therapies for prevention or treatment of infections such as Clostridium difficile, acne, and bacterial vaginosis. Live biotherapeutic products (LBP) manufactured from commensal bacteria are being investigated by many companies and several clinical trials are underway.

Anaerobic Cultivation & Containment Required for Microbiome Research

Many of these commensal microorganisms for the manufacture of LBP are obligate or strict anaerobes and spore forming organisms,  presenting unique challenges to the emerging microbiome therapeutic space.  Expertise and proper equipment for anaerobic cultivation and proper containment of spore forming organisms is lacking in the industry and only a handful of contract manufacturing companies have the capabilities to perform GMP manufacturing anaerobic organisms, creating a bottleneck.

An alternative for companies is to build their own GMP facility, as Seres Therapeutics has done.  But start-ups typically do not have the funds to build their own facilities thus the CMO backlog impacts timelines.  Most CMO’s quote a wait of 9-12 months for projects to begin.  So how will these burgeoning companies meet their aggressive timelines to produce their LBP for clinical trials?

Questions to Ask Partner GMP Labs

If you are a startup, sound advice is to start conversations now with potential CMOs and find out if their capabilities align with your organism cultivation requirements and specifications.

• How many Live Biotherapeutic Products have they produced and released?
• What is their experience with anaerobes?
• Can they work with spore formers?
• What are their QC and QA capabilities and regulatory support?
• What scale production is possible?

List Labs Is well suited to Partner in GMP Microbiome Research

List Biological Laboratories, a boutique contract manufacturing company, has the expertise and infrastructure for manufacturing both obligate and strict anaerobes and spore forming organisms.  List has over 30 years’ experience cultivating anaerobic organisms.  We have produced master and working cell banks and LBP for several customers currently in Phase 1 and 2 clinical trials.  In addition, we have expertise in the development of the non-trivial required purity/bioburden assays, including USP61 and UPS62, for testing and release of these unique live microorganism products.

Contact List Labs to get your microbiome research project off the ground today.

By:
Debra Booth, VP of Operations
Linda Eaton, Ph.D., VP of Research & Development
Stacy Burns-Guydish, Ph.D., Senior Director of Microbiology
PJ Nehil, Sales & Distribution Coordinator

Dear Researchers Everywhere,

List Labs recently exhibited at the 2016 BIO International Convention. As a producer of bacterial products for research, as well as a provider of custom laboratory services, we were excited to meet with current and potential customers. We were eager to gain some insight into the current and future state of biotechnology and the up and coming field of microbiome research. But you never know exactly how you’ll feel until you spend the time in the conference exhibit hall. We were very pleased to see that we are a part of an industry that is moving forward at the pace of a start up, fueled by the novel ideas and intellect of many scientists.

Last week, thousands of people filled the Moscone Convention Center in San Francisco. The event was brilliantly organized and the venue was strategically arranged. The various pavilions were organized by state or country and some by specialty. It was a great opportunity to network and identify new sources for projects and services. Attendees were CEO and business development folks interested in learning more about what exhibitors have to provide. At our booth, we talked about immunotherapy, live biotherapeutics, contract manufacturing, GMP production, and more. It was a pleasure to shake hands with many customers, distributors, and colleagues and discuss ways we can partner with them to move their research forward.

We also had the opportunity to meet with vendors, in shipping, supplies and services. These vendors are critical to delivery of our biological and therapeutic products, and we benefited from learning about their new offerings as strategic partners. The enthusiasm was palpable from both exhibitors and attendees. At this event, we didn’t just meet industry veterans. We met many young scientists and job seekers looking for their first break. Some even came directly to us to hand-deliver their resumes. The event had a job expo, fueling another layer of energy and opportunity for exhibitors. We were resident in the California Pavilion where we learned that the State of California has a Biosciences Training Program, which will help companies pay for new employment training. Community colleges around the country are encouraging students to contribute to the future of biotechnology through clinical and regulatory apprenticeships. It’s great to see that science is providing opportunity for students in so many ways.

In closing, we found the 2016 BIO International Convention to be highly productive for our company. For those of you who didn’t get a chance to meet us at the convention, it’s very easy to reach us online and on social media. We would love to connect with you on LinkedIn, tweet with you on Twitter, like each other on Facebook and Google+. You can also check these accounts if you’re curious about your next opportunity to meet us at a conference. We even have a YouTube channel and a blog where you can learn more about us. We’d love to see your YouTube videos and read your blog if you have them as well. The future of biotechnology looks bright and we’re more excited than ever to be a part of it. We will definitely attend more events like this and we hope to see you at BIO 2017 in San Diego!

Regards,
Debra, Linda, Stacy, & PJ

Dr. Karen Crawford, President of List Biological Laboratories, Inc.

We will be exhibiting at the 2nd Annual Translational Microbiome Conference at the Hilton Boston Back Bay on April 20-21. We are also proud to be a sponsor of this event.

If you will be in attendance, stop by the List Labs booth and chat with Karen Crawford about your research in the microbiome area. Karen is the president of List Labs and would enjoy speaking with you about our areas of expertise and how we would be able to support your microbiome or live biotherapeutic product work. We love hearing what companies are developing and finding ways to help.

If you want to learn more about our capabilities, check out our website or one of our videos and let us know how we can help you better position yourself to meet your research goals and objectives.