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Process Development

What we can do for you

Depending on your needs and the exiswting skills of your in house team, BioReport Consultancy can provide a range of services such that at the end of the iniitial process development phase the team will be in a position to:

  • Select an approvable Cell Line with a productivity capable of supporting a cost effective commercial manufacture
  • Define Fermentation/Cell Culture Conditions which are scaleable and commercially viable
  • Define an Infection Protocol [virus products] which is scaleable and commercially viable
  • Recommend a robust scaleable Primary Recovery strategy which removes the bulk of non-product related contaminants from the process stream
  • Recommend a Separation approach which is productive and cost effective and delivers formulated bulk drug substance at the required quality
  • Provide guidance on a process strategy which can operate at scale using standard equipment and with holding steps allowing manufacture within the operational parameters of your facility.