The Istituto Biochimico Italiano has a pilot plant for the cGMP production of recombinant proteins, through fermentation processes from mammalian cells.
The plant has been authorized by the Italian Health Authority to work with class 2 GMOs, according to the law D.L. April, 12th 2001 n. 206.
Expert researchers follow the entire development and production process. IBI offers a complete service from the development of cell lines, the up and down-stream processes to formulation and analytical characterization. These different phases can be conducted in parallel from the beginning, guaranteeing a rapid development time and optimal results in the cGMP production of clinical batches.

Cell Lines

Ibi is able to develop cell lines using commercial or innovative expression vectors, according to the needs of the client, for the production of biopharmaceuticals from mammalian cells (CHO), Pichia p. and E. Coli.

Development of protein production methods

• Up-stream

Optimization of media
Fermentation in batch, fed-batch and perfusion
Process scale-up (to 200 Lt)
cGMP production of clinical batches

• Purification

Experience in protein purification
Study and scale-up of state of the arts purification processes
Microfiltration
Ultrafiltration
Chromatography (IEX, HIC, RP, AFC, SEC)

The analitycal characterization of proteins