OUR FACILITIESGMP INDUSTRIAL SCALE UP

DRUG SUBSTANCE
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We have several different options for the scale up. Our 20-lite, 150L and 300L fermenter are perfectly 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 and encloses the following materials, all including 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 pouches, vacuum sealed.

Executing scale up in an industrial GMP suite allows biose industrie to validate in process controls, industrial yields and cleaning methods.