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.
CoreBiome is a genomics platform company focused on accelerating discovery for customers in the pharmaceutical, agriculture, and research communities, to unleash the translational potential of the microbiome. The Company’s proprietary BenchMark™, BoosterShot™, and Core Analysis™ platforms provide a rapid and highresolution measurement and interpretation of microbial diversity. The recently launched BoostArray™platform provides an ideal method for the characterization of strain libraries. CoreBiome was founded in 2016 based on intellectual property originating from the University of Minnesota. The founding team has collective experience processing and analyzing hundreds of thousands of microbiome samples.
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.
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 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.
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.
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.
List Biological Laboratories, Inc.
Since 1978 List Biological Laboratories, Inc. has been the leading manufacturer of bacterial products for research. Leveraging decades of experience growing microorganisms, List Labs offers GMP manufacturing of Live Biotherapeutic Products (LBP) for clinical trials. We have developed products for many microbiome companies from technology transfer through GMP production, including cultivation of aerobic, anaerobic and spore-forming bacteria. List Labs is your ideal full service CDMO, with the flexibility and expertise to customize a successful development path for your microbiome product. Contact us to discuss your project soon!
Loop Genomics is a DNA sequencing company with a vision to provide products that deliver the most complete and accurate human microbiome data. Loop technology meets the critical need for high-resolution phylogenetic data using long-read sequencing and single molecule abundance quantification, with an innovative approach that transforms existing short-read sequencing machines. Our long-read single molecule microbiome sequencing products enable drug R&D pipelines to discover previously inaccessible metagenomics information at unprecedented scale, while leveraging their existing sequencing systems and workflows.
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)
With more than 20 years’ experience, Wacker Biotech is “THE MICROBIAL Contract Development and Manufacturing Organization” (CDMO) – the partner of choice for the manufacturing of therapeutic proteins, vaccines and live microbial products. Wacker Biotech`s sites in Jena, Halle (Germany) and Amsterdam (Netherlands) provide a complete range of services for the development and GMP-compliant manufacture of biopharmaceuticals. The service portfolio covers process & analytical development and the GMP manufacturing of biologics for clinical trials and commercial supply.
Anaerobe Systems has over 40 years of experience specializing in manufacturing pre-reduced anaerobic culture media, anaerobic transport media, and anaerobic chambers for the cultivation and transport of anaerobic organisms. We specialize in producing customized media formulations to meet our customer’s unique requirements and have a range of standard products that support the growth of human microbiota. Anaerobe Systems manufactures and sells anaerobic chambers which provide an oxygen free environment for manipulation and growth of anaerobic organisms.