Lead Partner
Biose Industrie
Biose Industrie is a Contract Development and Manufacturing Organization (CDMO), specialised in Live Biotherapeutic Products. Founded in 1951 by pharmacists and microbiologists, Biose Industrie has been manufacturing drug substance and drug products based on microorganisms for 60 years. Company, with 10 000m² of GMP facilty, offers product development at laboratory and pilot scale specialised in microbiology for aerobie and anaerobie strains and is Drug GMP certified for the manufacturing of API, clinical batches and commercial products.
Expertise Partner
Clinical Microbiomics | MS-Omics | Cosmos ID | DNA Sense
We offer end-to-end microbiome science solutions from discovery through clinical validation: short- and long-read DNA sequencing, metabolomics, RNA sequencing, multi-omics analysis and systems biology expertise. Pipelines are supported by CLIA-certified & ICH-GCP compliant NGS, metabolomic, and bioinformatics solutions. Access results via the CosmosID-HUB – a user-friendly cloud software for metagenomic and comparative analysis – or through customized reports. Bioinformatic pipelines enable clonal-level resolution, engraftment analysis correlated to phenotypes, and in-silico strain screens that de-risk selection and reduce development time.
BA Sciences
BA Sciences is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2017 certified analytical laboratory headquartered in Salem, NH. BA provides testing services to Pharmaceutical, Biopharmaceutical and Medical Device companies worldwide including: Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, Impurities Testing, Advanced Therapeutics and Extractables & Leachables Studies.
Bacthera
Bacthera, a CDMO located in Switzerland and Denmark, was founded to enable the Live Biotherapeutic Industry realize the therapeutic value of LBP's. We do so by supporting our customers with microbiology know-how, process expertise and industry changing innovation from pre-clinical to commercialization, from start-up to multinational pharma company, with best-in-class process technologies, strictly anaerobic strain handling and experienced staff. In sum, Bacthera actively work to de-risk the growing LBP industry with frictionless CMC development services and manufacturing solutions.
Program Partner
List Biological Laboratories, Inc.
List Labs is an experienced contract development and manufacturing organization (CDMO) harnessing bacteria’s potential for a healthier world. We offer a refreshingly flexible approach to clients seeking a CDMO for Live Biotherapeutic Products (LBP) derived from beneficial bacteria. Partner with List Labs as your CDMO and experience our uniquely collaborative and transparent culture. With over 40 years of experience, our expertise encompasses aerobes, anaerobes, and spore formers, process development and scale up, analytical development and QC testing, aseptic filling, purification, lyophilization, and cGMP manufacturing for clinical trials and future commercial launch. List Labs produced the first LBP for clinical trial, before LBP was even an acronym, followed by dozens of products that led to successful clinical LBP programs. List Labs provides a solid foundation in science, purpose-built state of the art facilities, and a passionate team to ensure the success of your LBP project.
One Codex
Accelerate your microbiome research with One Codex. Leading institutions trust One Codex for everything from microbiome sequencing to data analysis to reporting. Our advanced algorithms and curated database provide the most accurate picture of complex metagenomic samples. Meanwhile, an intuitive web-based interface makes data accessible to both bench scientists and computational biologists. We make it easier to solve problems in biology through genomics. Go from stool sample to results quickly and easily - One Codex gives structure to complex datasets, answering questions like: “What microbes are present?” and “What are they doing?”. An easy-to-use web platform, simple APIs for accessing data programmatically, and integrations with Illumina BaseSpace and other tools allow you and your collaborators to analyze hundreds or thousands of samples.
Sacco System
Sacco System is the international biotech hub for food, nutraceutical, and pharmaceutical innovation. Cultures, probiotics, rennet, and many other ingredients to promote the culture of food and life. Innovative and customized solutions capable of responding to modern challenges of the Food & Health sector worldwide. After more than 70 years, CSL continue to focus on probiotic manufacturing, research and development for nutraceutical and pharmaceutical fields. Our know-how is not limited to LAB, but with our two facilities drug- GMP certified we can support companies in the development, process validation, and commercial production of probiotics, postbiotics, Next-Generation bacteria (obbligate aerobes and anaerobes strains) and biotherapeutics (BPs).
Wacker Chemie AG
Wacker Biotech is “THE MICROBIAL CDMO” – your partner of choice for process development and contract manufacturing of biopharmaceuticals (live microbial products, proteins, vaccines, plasmid DNA and mRNA). With its LIBATEC® platform, WACKER BIOTECH offers its clients vast experience in process development, optimization and manufacturing of Live Microbial Products (LMPs). LIBATEC® is suitable for a wide range of LMPs and fermentation regimes, allowing aerobic as well as specific anaerobic bacteria to be used. WACKER BIOTECH can perform such processes in a monoseptic manner, ensuring maximum culture purity and allowing use for specific routes of administration.
EzBiome
EzBiome is a microbiome company specialized in precision taxonomy, curated databases, and cutting-edge genomic intelligence. Our mission is to accelerate the discovery and development of novel transformative therapeutics and companion diagnostics for microbiome-related diseases.
Our vision is to become world’s most customer centric microbiome company serving the global community with revolutionary platform and solutions to educate, inspire and harness microbiome treasure for the benefit of mankind.
Catawba Research
Catawba Research is a full-service contract research organization (CRO) providing clinical management expertise and services to pharmaceutical, device, formulation development, and biotechnology companies. Our executive leadership team has over 160 years of experience and is comprised of industry professionals from large global pharmaceutical, small- and medium-sized biotechnology, global full-service CRO, and eClinical technology backgrounds. Our cross functional team of dedicated personnel have successfully supported over 520 large- and small-scale clinical trials across their careers in dozens of therapeutic areas.
“The Catawba Way” – our nimble and customizable delivery model – allows us to leverage our experience and expertise to serve as both an end-to-end strategic service provider as well as a functional service provider (FSP) to our sponsors while maintaining the highest focus on timely project delivery and submission-ready data quality. Since our inception 2014, we have supported over 87 clinical trials (10 in microbiome), and our work has delivered 33 regulatory agency approvals for sponsors.
As an international service provider, we have headquarters in North Carolina, USA and Mumbai, India. Our service offering also includes a Site Management Organization (SMO) based in Texas, USA.
Event Partners
EXPERT'Biome
EXPERT'Biome, CDMO by Lallemand, is leveraging 90 years of know-how of Lallemand Health Solutions to support our partners in the development and production of their probiotics and LBP:
- Robust R&D expertise - a team of 40 people, 25+ on-going clinical trials, 430+ publications
- State-of-the-art GMP pharma production capabilities - 3 plants (France and Canada), from 480L to 20,000L
- An experienced regulatory team - 200+ approved food supplements, 40+ claims, 30+ API/Drugs
Exhibition Partners
Anaerobe Systems
Anaerobe Systems produces the world’s only true pre-reduced anaerobically sterilized (PRAS) culture media: poured and packaged under anaerobic conditions. Founded over 40 years ago, for scientists by scientists, Anaerobe Systems has discovered practical and efficient ways to maximize anaerobic culture techniques.
Biomodels
Biomodels LLC, a preclinical CRO, conducts predictive and translational studies for biotechnology and pharmaceutical companies in the areas of cancer/cancer supportive care, inflammatory & autoimmune diseases, and fibrosis, in addition to several other clinical indications. Biomodels specializes in (non-GLP) efficacy studies that optimize dose, schedule, and define mechanism of action. Additionally, Biomodels' state of the art Germ-Free and Gnotobiotic animal facility allows for the analysis of the role of the microbiota both in disease pathogenesis and in therapeutic efficacy.
SGS Quay Pharma
Quay Pharmaceuticals is a privately owned CDMO working from FDA and MHRA inspected facilities. We are licenced to formulate and manufacture finished dosage forms for live biotherapeutics as well as small large molecules. In the live biotherapeutic space we work with consortia and single strain for drug delivery in oral, pessary and topical formats. Working as part of your team we rapidly and effectively bring products through development to First in Human studies to deliver success. We have worked on more than 50 plus strains from Phase I to Phase III projects and we are currently preparing for Commercial project.