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 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.
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.
Every day, QIAGEN serves 500,000 customers globally, all seeking insights from the building blocks of life – DNA and RNA. Delivering Sample to Insight solutions for molecular testing, we enable scientists and clinicians to achieve breakthroughs in life sciences research, molecular diagnostics and drug development. We make improvements in life possible.
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.
Biose Industrie is the world leading fully integrated CDMO for LBP process development and production of both drug substance & Drug Product. We have nearly 70 years’ experience of developing and producing bacteria under full GMP pharma conditions. We’ve produced many strict anaerobes in large industrial volumes for later stage clinical trials and currently service a large share of the LBP market place upon the back of the excellent results we have offered for our clients.
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.
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 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, 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.
Fluid Air has established itself as an innovator in developing equipment for the modification and creation of powders and particles, and provider of customized solutions to solid dosage process challenges across several industries including; pharmaceuticals, nutraceuticals, foods, fine chemical & cosmetics. PolarDry® Electrostatic Spray Dryers can produce small-scale samples with minimum product loss, making research of new products more efficient and cost-effective before committing to full-scale testing. PolarDry® utilizes electrostatic technology which drives water to the shell and active to the core, lowering the evaporation temperature and eliminating active ingredient loss, degradation, or denaturalization, resulting in stunning encapsulation efficiency.
The BioLector® microbioreactor enhances bioprocess development and microbial screening efforts. Researchers can conduct bioprocess scale-up experiments (aerobic / microaerophilic / strict anaerobic) with high efficiency and excellent data quality, at microscale costs. The system utilizes a shaken microtiter plate (MTP) providing high-throughput and real-time measurements of: DO, biomass, pH and fluorescence. The combination of high-throughput and high information content makes the BioLector® system an invaluable tool for any microbial or microbiome bioprocess development laboratory.
Altis Biosystems has a patent-pending stem cell platform that recreates the human intestinal epithelium in a high-throughput format for drug screening and microbiome research. Altis provides a variety of services including, Inflammation, Barrier Function, Toxicology, and Drug Disposition and also sells the platform as a kit. Our goal is to reduce the time and cost of drug development with a platform that more accurately reflects native human biology and reduce the need for animal testing.
GALT's Prospector® platform enables massively parallel isolation, cultivation and screen of microbes from the microbiome. Highly dense arrays of > 6000 nanoscale cultivation chambers integrated with an instrument that automates the workflow enable access to 1000s of microbes in parallel for microbiome analysis at an unprecedented scale. Prospector will allow scientists in human health to harness the true diversity of microbial life and open up new opportunities for research and product development not possible with traditional cultivation methods.