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.
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.
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 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!
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.
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.
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.
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.
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.
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.
Karen Crawford, Ph.D., President
Eva Purro, Director of Quality Assurance
Dom C. Ouano, Marketing
While most of List Labs’ products are intended as research reagents (Research Grade), several can be produced as GMP products for use in humans. Below are key differences between the two.
Research Only VS Preclinical/Clinical/Human Use
Reagent grade products for research only are labeled “not for human use” but are produced using good laboratory practices. These reagents are readily available on our website and any quantity can be purchased. Products intended for human use are produced under cGMP (current Good Manufacturing Practices, see the Code of Federal Regulations 21 CFR 211) and are provided to clients with a customized contract.
cGMP = Higher Production Standards
Producing compounds under cGMP regulations is a more costly process compared to reagent grade. cGMP compliance includes all aspects of production: documented training programs, QA issued production records, dedicated production suite preparation, testing and release of raw materials, analytical method qualification dedicated supplies, and validated cleaning methods. In addition, a Drug Master File may be submitted to the FDA, which can be cross referenced by our GMP customers.
One example of a product produced as both reagent grade and GMP grade is HPT™ E. coli O113 LPS. Although a chemist may not be able to tell the difference between the reagent grade and the cGMP material, the difference is in the compliance to the GMP’s as described above. Our reagent grade material is produced with good laboratory procedures, however it is not compliant to GMP. Consequently, reagent grade E. coli LPS is not for human use and cGMP LPS may be applied “for human use” per FDA approval. cGMP for human use is not so much a property of the E.coli LPS as it is describing the environment and procedures surrounding the preparation of the compound.
Our LPS from E. coli O55:B5 or E.coli O113, Products #203, #423 and #433, are reagent grade products and are often used in research, particularly for inducing the maturation of Dendritic Cells.
We also provide cGMP LPS from E.coli O113 on a contract basis, which is made compliant to GMP and is appropriate for FDA approved use in humans.
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.
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.