contact@biose.com
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OUR FACILITIESGMP COMMERCIAL PRODUCTION

Drug GMP manufacturing for bacteria based Drug Substance and Drug Product
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Biose Industrie has been manufacturing Live Biotherapeutic Products for more than 60 years. We are drug GMP certified and regularly audited by:

Health authorities including the French ANSM, the Korean FDA and the Russian Ministry of Health
International pharmaceutical companies that dispose of our full and comprehensive CMO services, equipment and staff expertise according to their needs

Drug Substance

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 of using a support vessel for inoculum preparation and feed processing
Anaerobic and aerobic fermentation, with the possibility of using the culture medium with any kind of gas (eg. oxygen, nitrogen, etc.)
Biomass concentration
Cryoprotectant mixing, with temperature control down to 5°C
Large freeze-drying capacity (25 square meters for up to 200 liters of dried product)
Bacteria-friendly milling
Packaging of concentrated powders in vacuum-sealed pouches, vacuum sealed and at -20°C
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 or long release technology
Enteric coating
Capsules including anaerobically contained systems
Banding

Depending on your development and required volumes, we are also in the position to study 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