Confirmed Partners for 2022
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 programmes 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.
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 knowhow, process expertise and industry changing innovation from pre-clinical to commercialization, from start-up to multinational pharma company, with bestin- 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.
CosmosID® provides end-to-end solutions unlocking the microbiome. A provider of CLIA-certified & ICH-GCP compliant NGS Services and Bioinformatics Solutions, CosmosID offers a range of validated and optimized workflows for research and development.
CosmosID also offers independently validated, industry-leading pipelines for processing metagenomic data, yielding multi-kingdom, strain-level resolution with leading sensitivity and precision. Results can be accessed via CosmosID-HUB, a user-friendly and interactive software for comparative analysis of microbiome data, complete with dynamic charts, visualizations, and statistics
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.
Quay Pharmaceuticals is a privately owned CDMO working from FDA and MHRA inspected facilities. We are licensed to formulate and manufacture the finished dosage forms for live biotherapeutics as well as small and large molecules. In the live biotherapeutic space we work with consortia and single strains for drug delivery in oral 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.
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.
Atlantia Clinical Trials Ltd is world class in delivering ICH-GCP standard clinical studies for functional foods & beverages, nutraceuticals, medical foods and dietary supplements. We have extensive clinical expertise in the areas of digestive health, (including camera endoscopy), mental (stress, cognition), cardiovascular (FMD), joint, immunity, sports performance, ageing, weight management, skin and nutrient uptake. We own our clinics where we conduct our acute, observational and intervention studies. Our subject database is now more than 13,000 with pre-disease markers.
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.
Fluid Air is a division of Spraying Systems Co., the world leader in spray nozzle technology. Spraying Systems Co. was founded in 1937 and has established its leadership through the development of its extensive global sales force, its global manufacturing capabilities, including twelve manufacturing plants worldwide, and its innovative, solution-oriented approach toward customers. Founded in 1983, Fluid Air Inc. specializes in solid dosage technology. Fluid Air has always excelled in its ability to develop quality and robust products tailored to its customers' needs. Working together with Spraying Systems Co., Fluid Air now has a strong international presence with best-in-class global service. With an aggressive will to develop new and innovative technology, Fluid Air continues to push the boundaries of what is possible and always aims to satisfy the customer.
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.
Luina Bio Pty Ltd is one of Australia’s most experienced biopharmaceutical contract manufacturing organisations. Luina Bio is conveniently located in Brisbane, Queensland. We offer an inclusive set of services including process development and GMP manufacture of recombinant proteins, vaccines and live bio-therapeutics for human and veterinary use. We can produce material for preclinical studies and clinical trial GMP batches for Phase 1, 2 and 3 clinical studies. We have more than 20 years of contract manufacturing experience with a dedicated team of highly educated and trained personnel.