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), specialized 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 specialized in microbiology for aerobie and anaerobie strains and is Drug GMP certified for the manufacturing of API, clinical batches and commercial products.
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.