Microbial production

Mammalian production

 

Biovian provides mammalian cell based production of API´s and Drug Substances. Biovian has separate mammalian GMP-manufacturing unit comprising  state-of-the art bioreactor, harvesting equipment and several downstream suites and equipment which allows flexible production scenarios:

 

Upstream Processes


  • Capacity up to 100 L (working volume) in Disposable Wave-biorector
  • Capacity up to 500 L (working volume) in disposable bioreactor stirred tank bioreactor (expansion on-going)

  • Harvesting by depth filtration
    - Tangential flow filtration units for harvest clarification and further processing

 

Downstream processes

  • Comprehensive purification solutions (low pH inactivation, chromatography, membrane processes, tangential flow filtration and nanofiltration 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.)