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OUR FACILITIESGMP INDUSTRIAL SCALE UP

DRUG SUBSTANCE
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We have several different options for the scale up. Our 20L, 150L and 300L fermenters are perfect scaled copies of industrial fermenters and allow for a seamless transfer to industrial scale.

The scale-up unit is integrated in a full GMP suite. It includes the following elements with Cleaning in Place (CIP) and Sterilization in Place (SIP):

Fermenter with working volume from 20 to 300 liters
Plate centrifugation
TFF Option
Cryoprotectant mixing tank
Freeze drying unit
Grinding
Bulk powder packaging in vacuum sealed pouches.

Executing scale up in an industrial GMP suite allows Biose Industrie to validate in-process controls, industrial yields and cleaning methods.