OUR FACILITIESGMP COMMERCIAL PRODUCTION

Drug GMP manufacturing for bacteria based Drug Substance and Drug Product
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Biose® industrie has been manufacturing living bacterial products for more than 60 years. We are drug GMP certified and regularly audited by:

Health authorities including French ANSM, Korean FDA, Russian Ministery of Health
International pharmaceutical companies, We offer full and comprehensive CMO services, as we make our equipment and staff expertise available according to your needs.

Drug Product

Our GMP manufacturing suite offers a wide range of possibilities:

GMP Working Cell bank (WCB)
Fermentation of 150,300 liters and any volume from 800 to 5000 liters, with the possibility to use a support vessel for inoculum preparation and feed processing
Anaerobic and aerobic fermentation, with the possibility to enrich the culture medium with any kind of gas (ex: oxygen, nitrogen, etc.)
Biomass concentration
Cryoprotectant mixing, with temperature control down to 5 degrees Celsius
Large freeze drying capacity (25 square meters, up to 200 liters of dried product)
Bacteria-friendly milling
Packaging of concentrated powders in pouch, vacuum sealed and at -20 degrees Celsius
Broth temperature control, including fermentation stabilization by cooling
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Finished dosage form

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We manufacture the following forms, all of which include live microorganisms:

Tablets, including slow/long release technology
Enteric coating
Capsules including anaerobically contained systems
Banding

Depending on your development and corresponding volumes, we are also open to making investments in new technologies.

Finished products can be packaged as:

Alu/alu blisters
Alu/Plastic Blisters
Creams & Oils
Glass/plastic jars
Glass jars under vacuum
Stick/sachet packs