Confirmed Partners for 2020
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.
CosmosID®, based in Rockville, MD, provides award-winning Next-Generation Sequencing & Bioinformatics solutions for unlocking the microbiome through rapid identification and characterization of microorganisms for pharmaceutical R&D, molecular diagnostics, public health, food safety, agriculture, and environmental applications. CosmosID’s CLIA-certified laboratories offer end-to-end solutions; from study design to sample collection, extraction, library preparation, sequencing, data analysis and publication support. Lastly, CosmosID’s user-friendly and independently validated cloud-based application returns strain-level metagenomic analyses with industry leading sensitivity & precision along with access to the world’s largest database for microbial genomics.
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.
The recent merger of Diversigen, CoreBiome, and DNA Genotek positions these industry leaders to propel microbiome discovery and clinical application in 2020 and beyond. Diversigen’s established expertise and focus on customer service, along with CoreBiome’s innovation in microbiome analysis and DNA Genotek’s easy, reliable sampling kits, pack a powerful combination for actionable microbiome insights.
Diversigen, CoreBiome and DNA Genotek Inc. are subsidiaries of OraSure Technologies. Inc.
Quay Pharma is experienced in formulation development and is one of very few companies licensed to provide clinical manufacturing materials containing live bacterial strains being targeted for delivery to, and in, the digestive, urogenital, otorhinologic and pulmonary tracts. Understanding the client dosing requirements for the live biotherapeutic, Quay Pharma can prepare a formulation development strategy to bring your live bacterial strain rapidly and effectively to First in Man studies aiming to provide a formulation with the best chance of clinical success.
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, aging, weight management, skin and nutrient uptake.
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.
LuinaBio is Australia’s most experienced biopharmaceutical CDMO’s with 20 years’ experience in our field. More specifically Luina carries out microbial aerobic and anaerobic fermentation, yeast fermentation, cell banking, vaccine production, process development, analytical services, stability studies, storage and distribution of investigative material for clinical studies.
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.
Based on its pioneering research on the role of tissue microbiota inthe initiation of the inflammatory cascade leading to metabolic disorders, Vaiomer vocation is to contribute to the studies of disease mechanism, in clinical and basic research to discover innovative biomarkers, therapeutic targets and products. Vaiomer offers a unique platform to study the microbiome of low bacterial load samples (human or animal: blood, liver, brain, adipose tissue, muscle, bone marrow, MLN, bile, ascites and more)
Microbiotica is transforming personalized medicine with leading microbiome science, identifying gut bacteria linked to patient phenotype with unprecedented precision for the discovery of novel microbiome-based medicines and biomarkers of drug response.Microbiotica was spun out of Trevor Lawley’s Lab at the Wellcome Sanger Institute and is founded on a unique pipeline for culturing and genomically characterizing the entirety of the bacteria in the human gut for the first time. It has the world’s largest microbiome genome database and culture collection, a suite of translational in vitro and animal models, and state of the art bioinformatics and AI. The company has a focus on IBD and Immuno-Oncology, and a program in C. Difficile which is spearheading innovation in development of live bacterial products.
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.
BacThera positions itself as a leading contract development and manufacturing partner (CDMO) for live biotherapeutic products. It brings together best-in-class, and unique complementary capabilities from Chr. Hansen and Lonza, offering high fermentation yields, downstream process efficiency, guaranteeing high viability for oxygen- and moisture-sensitive live bacteria. Bacthera offers outstanding formulation and clinically-proven enTRinsic™ capsule delivery technology, together with expert analytical and regulatory support. We operate from upgraded existing facilities near Copenhagen (DK) and new facilities in Basel (CH) to serve pre-clinical to phase II projects. Additional facilities for phase III and commercial manufacturing are being planned in a pre-built facility in Visp (CH).
Ardigen is a Life Science computational partner in the era of Artificial Intelligence. We provide comprehensive services that leverage our domain knowledge and expertise in bioinformatics, machine learning and software engineering together with our proprietary technology. Ardigen platforms for neoepitope, biomarker, and microbiome research facilitate the improvement of the response rates in immuno-oncology.
CPS Research is a highly successful clinical site for Pharmaceutical, Probiotic, OTC, and Device Research. This experience ensures we can help develop projects from protocol design, collection of trial data, through to compilation of the final study report. We understand recruitment issues are the primary cause of delay in the completion of most clinical trials. We have proven recruitment methods for our on-site studies, we are now able to utilise this expertise by offering recruitment services for international clinical research.
At Clinical Microbiomics we offer 'full-service' microbiome analysis covering the entire workflow, from extracting DNA from your study samples, over sequencing to profiling and biostatistics, linking the microbiome to clinical outcomes. For us, full-service means supporting you through your study – from planning to the final report. This includes being available throughout your study, during the analysis and for interpretation and discussions of the results. Our clients come from different research areas, including academic institutions, global pharma, nutrition and biotech companies who are developing microbiome-targeted products.