Biologicals Manufacturing

The BDU has experience in the manufacture of a wide variety of biologicals for clinical trials.

The product portfolio includes monoclonal antibodies, plasmid DNA and recombinant proteins.

The manufacturing unit is made up of two independent suites, one for mammalian and one for microbial production, which can be run simultaneously. 

The Unit is operated according to cGMP.

The relevant capacities are:

• Fermenter - 30L, Hollow Fibre, Continuous
  
  
• Spinners - 100L
  
  
• Downstream Processing - chromatography and centrifugation processes are used in the purification of the drug substance.  Endotoxin removal steps are included in the process.
  
  
• Cell banking - the Unit is able to create master and working cell banks.  The BDU is also able to create transfected cell lines according to cGMP.  Cell banks are stored on site.
  
  
• Filling - only vial filling is available on site.  The Unit uses an external group for filling ampoules.