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: Rachel Berlin, Marketing Manager

List Labs provides expert GMP contract manufacturing services to aid you in developing product for your clinical trial. The List Labs difference is that we manufacture reagent grade biological toxins regularly for resale, which means that not only do we have current, state-of-the art facilities and equipment, but we also have the experience and expertise to provide our customers with the highest quality products available. We even have a GMP LPS product currently in stock. Here are five reasons List Labs can make a critical difference in your success as a GMP manufacturing partner.

1. Product Manufacturing Experience

List Labs has nearly 40 years of experience cultivating anaerobic and aerobic organisms. Because we manufacture our own products, we are up to date with the most current regulations and best practices for the highest quality of product manufacturing. We are used to cultivating hard to grow organisms and thrive on the challenge.

2. Biological Toxins Expertise

Our team of scientists, many with PHDs, have the expertise for manufacturing obligate anaerobes, spore forming organisms as well as aerobes. The majority of List Labs’ scientific management team has been here for over 20 years and has vast experience manufacturing biological toxins for research. As experts in their field, our scientists utilize their expertise to produce the highest quality research reagents on the market.

3. Quality Research Reagents

List Labs produces only the highest quality products for our customers to conduct their research. We are known for our quality products and attention to detail throughout the industry. Over the past 40 years in business, List Labs has honed our processes and facilities to produce only the highest quality research reagents and GMP compliant products.

4. Facilities Designed for GMP

Our state-of-the-art facility was designed with GMP work in mind and is constantly enhanced with new equipment and more efficient processes. Our lab provides containment for BL2 and BL3 organisms and spores, as well as segregation of projects. Contact us to come visit us and tour our facility.

5. GMP Capabilities

List Labs’ contract research & manufacturing capabilities include analytics, process development, media optimization, downstream and upstream processing and bulk and final product lyophilization. Most of our cultivation and harvesting operations are in full closed systems. We are also capable of working with spore formers, which many organizations are unable to work with due to the difficult nature of these strains and regulatory compliance. List Labs is one of only about 16 private companies in the US registered with the Federal Select Agent Program.

When choosing your GMP partner – make sure it’s someone you can trust. Consider List Labs for your next GMP project.

Contact us today! 

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

Since 1978, List Labs has been known as a manufacturer of fine research reagents.  Located in Silicon Valley, our company is woman-owned and managed.  We enjoy long-standing relationships with many researchers who have used our products for decades, bringing the continuity of List’s products along with them as they move up to new career opportunities.

Full Range of Contract Manufacturing Services

In addition to our catalog products, we offer a full complement of professional services, including:  GMP Contract Manufacturing, Production of Live Biotherapeutics, Contract Research, Formulation/Lyophilization and Navigating both Toxin Compliance, and Regulatory Requirements.  Our manufacturing  and biocontainment experience, and our well-established record of working with partners to successfully bring products to market makes us a great service provider to companies of all sizes.

Full cGMP Facility

List Labs offers a full cGMP facility, and labs designed to meet the most exacting requirements including biocontainment. See our equipment list here. Our scientists are experts at working with pharma, start ups, government and entrepreneurs to further their research, to produce API , and to perform testing.  We extend our clients’ capabilities!

Start Your Partnership with List Labs Today!

If you have a project and you’d like to work with a partner who can work independently or as a member of your team, has their own state of the art lab suite, understands key requirements and navigating regulations implicit in toxin production, then contact us to discuss your needs.

List Labs has a compelling history of successful partnerships, ask us to tell you how we’ve helped bring major products to market and why we are a critical link to the scientific success of the work we do.  Check out Citations where our products have been used in research.

We will be attending BIO2014 in San Diego June 23-26 where we will be meeting with companies who have an interest in our wide range of Professional Services.  We are also happy to arrange a meeting and tour at our California office. Just email us.