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.
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 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.
Bio-Me is transforming microbiome analysis, making it possible to analyze hundreds of fecal samples in less than a day, with high resolution and reproducibility and at an affordable cost. Combined with our exclusive biobank and extensive patient database, Bio-Me’s Precision Microbiome Profiling platform (PMP) will enable microbiome-based Companion Diagnostics and discovery of novel drug targets to improve health and well-being worldwide.
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.
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)
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.
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.
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.
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.
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.
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!
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).
Biomodels provides its clients with access to selected predictive models in the areas of cancer, cancer supportive care, radiation therapy and inflammatory diseases. In addition, Biomodels is able to provide its clients with superior pre-clinical advice through a series of collaborative relationships with leading academic researchers and institutions. As a result of these collaborative relationships, Biomodels’ clients receive superior research together with the confidence of knowing their results can be relied upon to assess the potential for clinical success. Several of the world’s largest and most respected pharmaceutical companies, as well as many small and midsize companies, regularly call on Biomodels for outsourced preclinical research.
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.