GMP Industrial Scale Up
R&D’s 20-liter fermenter, which is the last step in our lab development, is a perfectly scaled copy of industrial fermenters and allows 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 100 to 300 liters
- Plate centrifugation
- Cryoprotectant mixing tank
- Freeze drying unit
- Bulk powder packaging in pouches, vacuum sealed.
Executing scale up in an industrial GMP suite allows biose® to validate in process controls, industrial yields and cleaning methods.