Aseptic fill finish

Microbial Production

 

Biovian provides microbial and yeast based production of API´s and Drug Substances. Biovian has separate microbial GMP-manufacturing unit comprising  state-of-the art fermenters, harvesting equipment and several downstream suites and equipment which allows production of both secreted and intracellular products:

 

Upstream Processes

  • Capacity up to 220 L (working volume) in SS-stirred tank
  • Capacity up to 100 L (working volume) in disposable bioreactor
  • Fermentation of wide range of bacteria (aerobic, anaerobic)

  • Continuous centrifugation

  • Tangential flow filtration units for harvest clarification and further processing
  • Homogenization equipment

 

Downstream processes

  • Comprehensive purification solutions (refolding, chromatography, membrane processes, tangential flow filtration processes)

 

Aseptic Fill&Finish

  • Formulation and final Drug Product manufacture

  • Two automated filling lines, filling in vials

  • Batch sizes typically 200 - 7000 vials

  • Lyophilisation

 

Analytics

Biovian provides integrated analytical Quality Control services to support Drug Substances and Drug Product release. Biovian QC-laboratory complies with the Ph.Eur. and USP.

 

  • Product specific assays
  • Impurity analysis

  • Cell based assays

  • Microbiological QC and safety assays (Sterility, Bioburden, Endotoxin etc.)