Late Development

Now you have data from your R&D colleagues. Here is the process they have developed. Can it be improved, how does it scale, what are resources requited and will it fit?

Often processes are developed with the clinical trials in mind, with BioSolve Process you can quickly evaluate how it translates to larger manufacturing scales and identify the Bill of Materials.  In addition you can determine the Cost of Goods for various manufacturing options and start the too evaluate facility fit.

Using the data given by your R&D colleagues, you can further evaluate:

  • Whether the current vessels or single use systems available in the facility is enough to handle new process scale buffer and media
  • How it scales when it goes to Clinical Trial Scale and ultimately to Manufacturing Scale
  • Using tool such as Advanced Scenario Analysis, our users can evaluate thousands of “what if” scenarios. Those highly configurable analysis tool gives user to conduct their Design of Experimental type of analysis with BioSolve Process.
  • Data produced by Advanced Scenario Analysis is used to produce graphical business insights which you can readily share with your colleagues or present to the senior management/board Allowing them to visualise the impact of what ifs such as improved process etc.
  • The PMI (Process Mass Intensity) tool integrated in BioSolve Process you can quickly understand the environmental impact of proposed change (using ACS methodology)