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Established since 1951, we provide a full range of services as a CDMO for Live biotherapeutic products (LPB).

Contact us

+33 4 71 46 80 00

info@biose.com

24 Avenue Georges Pompidou, 15000 Aurillac, France

Mon - Frid, 8 AM - 5 PM

Closed on Saturday - Sunday.

GMP Industrial Production

Drug GMP manufacturing for bacteria based API and finished dosage forms

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.

API

Our GMP manufacturing suite offers a wide range of possibilities:

  • GMP Working Cell bank (WCB)
  • Fermentation of 300 liters and any volume from 800 to 3500 liters, with the possibility to use a support vessel for inoculum preparation
  • Anaerobic and aerobic fermentation, with the possibility to enrich the culture medium with any kind of gas (ex: oxygen, nitrogen, etc.)
  • Broth temperature control, including fermentation stabilization by cooling
  • 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

Finished dosage form

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

  • Tablets, including slow/long release technology
  • Capsules
  • Capsules filled with living bacteria and hormones (dedicated workshop)
  • Sticks, under nitrogen if requested
  • Liquid forms (under development)

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
  • Glass/plastic jars
  • Glass jars under vacuum
  • Stick packs