Boston Analytical, the Life Sciences Division of Alpha Analytical, is a cGMP compliant, FDA/DEA registered, ISO/ IEC-17025:2005 certified analytical laboratory located in Salem, NH. We can provide all of the identity, purity and potency analyses necessary to characterize your microbiome product. Boston Analytical has a proven track record with sponsors on a variety of Microbiome programs including both Spore Fraction and Defined Drug Product manufacturing processes. We employ Labware Inc’s™ LIMS & ELN software with on-line data access for your convenience.
Microbiome Therapeutics Innovation Group
Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and expand availability of life-changing and life-saving FDA approved microbiome therapies to patients.
Destiny Pharma PLC is a public UK biotech company listed on AIM and focused on infection prevention. It has two clinical assets which it is preparing for Phase 3 studies - NTCD-M3 for prevention of recurrence of C. difficile infection; and XF-73 for prevention of post-surgical S. aureus infections. Both NTCD-M3 and a preclinical SPOR-COV programme are both focused on the microbiome. Destiny is seeking commercialisation partners for these assets.
Arranta Bio is a contract development and manufacturing organization (CDMO) specifically established to focus on serving companies seeking to develop and commercialize therapies targeting the human microbiome. With a ten-year legacy as Captozyme, Arranta’s has a proven track record with 125 species in process development and contract manufacturing of live biopharmaceuticals, and provides the resources necessary to help clients to deliver promising new microbiome therapies to meet the needs of patients.
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.
Accelerate and transform discovery research and capitalize on the diverse opportunities of the microbiome with Diversigen. Diversigen provides comprehensive fee-for-service microbiome and metagenomics services focused on solutions to improve human, animal, and environmental health. Diversigen is at the forefront of setting industry standards for quality with a microbiome CLIA/CAP accredited, GLP compliant laboratory. Diversigen has extensive experience with highly diverse microbiome sample types and provides full project life cycle consulting services, building on research conducted at Baylor College of Medicine in the Alkek Center for Metagenomics and Microbiome Research. From pre-project consulting, study design, extraction and sequencing to complete bioinformatics analysis, Diversigen is your microbiome partner of choice.
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.
Bio-Me is setting the standard for next generation routine microbiome analysis with our Precision Microbiome Profiling (PMP™) platform. We enable rapid, accurate and highly reproducible microbiome analysis solutions down to the strain level thanks to our high-throughput qPCR-based platform. The PMP™ technology is perfectly positioned to support drug developers in their development pipeline and successful market introduction, as well as clinical researchers and pharma in diagnostic test development.
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.
CosmosID® is a global leader in supporting the pharmaceutical sector with CLIA-certified, ICH-GCP compliant microbiome and microbial isolate solutions for applications such as pre-clinical, clinical, CMC and regulatory support.
In addition to Next Generation Sequencing workflows, CosmosID also offers validated, industry-leading bioinformatics, yielding multi-kingdom, strain-level resolution with leading sensitivity and precision.
CosmosID-HUB, a user-friendly and interactive software for comparative analysis of microbiome data, complete with dynamic charts, visualizations, and statistics is used by researchers around the world for enabling downstream analysis & interpretation.
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.
Microba is a microbial genomics company that uses advanced machine learning techniques to analyse the gut microbiome to discover therapeutic leads. This is supported by a foundation of high resolution shotgun metagenomic sequencing; highly accurate bioinformatics, comprehensive
metadata and novel species discovery.
The Microbiome Initiative at MilliporeSigma is dedicated towards supporting the microbiome research community. Through the development of research tools and services our guiding focus is to ensure robust, multi-omics services through refinement of sample isolation, preparation and analytical characterization coupled with a standardized bioinformatic workflow designed to gain biological insight. Customers can benefit from using our broad portfolio of microbiome stand-alone products or packaged within our end-to-end service offerings.
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.
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.
Founded in 1983, Fluid Air specializes in solid dosage technology. A division of Spraying Systems, Fluid Air is an award-winning developer of equipment and custom solutions used for modifying and creating powders and particles. Our fluid beds, mixers, mills, tablet coating systems and patented PolarDry electrostatic spray dryers are used to help the pharmaceutical, nutraceutical, food, fine chemical, agriculture, and biopharmaceutical industries daily. Multiple case studies reveal that PolarDry consistently outperforms freeze drying, at the same cost as conventional spray drying, but with superior product stability and viability.
Invitae provides end-to-end research solutions for microbiome sequencing and bioinformatics analysis through the One Codex platform. Leading biotech companies trust Invitae to help de-risk their research and accelerate translation from discovery to clinical trials. Invitae offers flexible sequencing options and rapid turnaround times, with an extensible data platform to support a diverse range of analysis requirements.
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.
Luina Bio is Australia’s most experienced biopharmaceutical CDMO. We perform process development and GMP manufacture of:
- Recombinant proteins & vaccines
- Live Biotherapeutics
- Human & veterinary products
- Aerobic and fully anaerobic fermentation, BSL-1 BSL-2
We carry out microbial aerobic and anaerobic fermentation, technical transfer, cell banking, process development and validation, analytical development, GMP production and stability studies.
We offer 20 years’ expertise in bacterial/yeast production
- GMP material for: Pre-clinical, Clinical Phases 1, 2 & 3
- Highly cost competitive
- Flexible with fast access and turnaround times
- Access to Australia R&D Tax Incentive
Our contamination aware approach is crucial. By carefully controlling for contamination at every step of microbiome analysis, we provide reliable data that reflect the actual bacterial load of tissues rather than contaminants.
Arc Bio aims to create a healthier world by delivering robust sample-to-report microbial profiling workflows combined with data-driven health intelligence software tools to enable a new standard of care for disease detection and monitoring. Its Galileo™ platform represents the next generation of turnkey metagenomics solutions that combine next generation sequencing laboratory workflows with automated bioinformatics pipelines to deliver accurate, comprehensive, and quantitative microbial profiling.
The Galileo™ platform and Galileo™ ONE workflow are research use only and not intended for use in clinical diagnostics and patient management.
Gemelli Biotech develops and distributes precision diagnostics for diseases of the gut microbiome. The trio-smart® breath test measures the levels of hydrogen, methane, and hydrogen sulfide to aid in the diagnosis of SIBO, IMO, and excess hydrogen sulfide. The ibs-smart® blood test measures validated biomarkers of IBS, anti-CdtB and anti-vinculin, offering a positive diagnostic strategy for patients with IBS symptoms.
Microbiologics are the world’s leading experts and go-to collaborators in biological products and services, focused on creating a safer, healthier world. We are proud to support microbiome research and the opportunity it presents in discovering new life-changing therapies. Our microbiome services include isolation and testing of organisms that are constituents of the microflora, enumeration and characterization of probiotic or LBP strains, and evaluating effectiveness of probiotics and anti- infectives.
Precion applies mass spectrometry technology to provide targeted metabolite panels for profiling various chronic disease conditions and associated health areas for clinical research. Precion offers diagnostics and precision medicine assay formats for downstream applications. Our testing services for commercial and research customers provides data for various sample types and project objectives. We offer a range of targeted panels as well as custom developed panels for areas including microbiome testing of serum/plasma/stool samples.
ProDigest is a product leader in the development of unique laboratory models of the human and animal gastrointestinal tract (SHIME®). These models allow to obtain unique insight in gut processes associated to the intestinal fate of actives and to study the complete gut microbiome under controlled conditions. ProDigest is globally active as a service provider for food and pharmaceutical companies and installs its technology in selected R&D facilities around the world. Furthermore, ProDigest has set up a number of product development projects in relation to the gut microbiota management and novel biotherapeutics.
Microbiome products are at the center of our attention.
With a fully integrated product development and manufacturing infrastructure to support microbial products, Rise BioServices functions in a full-service CDMO capacity to prepare products for human use. We support emerging and established companies in all aspects of product development by leveraging our scientific and regulatory expertise in Live Biotherapeutic Products (LBPs) and other bacterial products.
Rise BioServices is at the forefront of the microbiome revolution and, with our technology edge, we offer uniquely engineered solutions for clean space manufacturing of novel microbiome-based medicines and products.