Now you have data from your R&D colleagues and you can see the process they have developed. Can it be improved, how does it scale, what are resources required, and will it fit?
Often processes are developed with the clinical trials in mind, and 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 to evaluate the 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.
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 and board members, allowing them to visualise the impact of ‘what ifs’ such as improved process.
Understand the scalability at early stage including buffer and media selection
The PMI (Process Mass Intensity) tool integrated in BioSolve Process you can quickly understand the environmental impact of proposed change (using ACS methodology)