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Biopharm Interview with University of Natural Resources and Life Sciences Vienna

General questions

       What are your name, organization name and position?

D    Alessandro Luigi Cataldo, PhD candidate at the University of Natural Resources and Life Sciences Vienna (when the interview has been conducted Summer 2020, Alessandro was still at BOKU University; he has now left and is employed elsewhere)

      Alessandro, would you classify yourself as a beginner, intermediate user or power user of BioSolve Process?

H    Power User

      Which version of BioSolve Process do you use currently?

       BioSolve 8

      What do you like most about BioSolve Process?

       Advanced Scenarios for Sensitivity analysis

      How steep did you find the learning curve for BioSolve Process? Where there any specific aspects of the tool that you found more difficult to learn than others?

L     For this question, I can only refer to earlier versions of BioSolve (v7 and v7.5), where not all current interfaces were available. For me, the most important aspect of handling an external calculation software is to learn, what exactly happens with the entire model after changing one specific value. For BioSolve this takes a lot of time without and visible progress until I know the impact of each cell. The learning curve after understanding this impact is very steep because it enables modification of the simulated process to adjust it to a critical unit operation. As an example, we compared several bind and elute chromatography steps with a periodic counter current chromatography using three pre packed columns with varying scale. For scaling each cost parameter needs to be redefined and interconnected with either total volume or amount of product to be realistic.

About your organization and BioSolve Process

       Alois, why did you choose to use BioSolve Process for this project with Alessandro?

      The BioSolve database is a very important feature, which helps us with the estimation of process parameters in a realistic dimension

      What was the most attractive thing about BioSolve Process when you chose this as a platform?

       Database in case we do not get all data by ourselves
Advanced Scenarios for sensitivity analysis
PMI calculations for water analysis
Bill of Materials and cost contribution of each parameter so we can communicate with our project partners efficiently

        In what ways could BioSolve Process create more value for you in the future?

       Graphical visualization for chosen outputs for advanced scenarios

Definition of a “reference process” should be possible

Intelligent scaling of devices, if the biggest available device range is exceeded, two smaller devices are implemented instead of an error occurrence

      Can you tell us about your recent publication(s)?

      We recently published an article in Journal of Biotechnology, where we used BioSolve for scaling and modelling of continuous downstream processes for monoclonal antibodies. In discussion with our partners from the industry we defined a process with a fixed bioreactor scale of 1000 L. Using BioSolve enabled the definition of output-based scenarios in order to determine, which unit operations are suitable for what scale. Furthermore, we analysed how different parameters (e.g. product titre) may influence this decision. Afterwards we could use the PMI calculation tool and analyse its results with the costs.

      About your recent publications, can you summarise your findings?

      Especially for the production of monoclonal antibody in Chinese Hamster Ovary cells the most critical cost contributors are linked to water consumption: Media demand, Protein A column scale, Labour and storage for media preparation etc. Overall performing an economic analysis for monoclonal antibody processes can be simplified if the PMI is considered properly. In our model using a continuous perfusion (1g/L) reduces the footprint, however more water is required to produce the same amount of product compared to fed-batch fermentation (4g/L). Hereby, increasing the perfusion titre is the most critical parameter, which should be focussed on during process development.

      How would you envision BioSolve Process usage in your department in the future?

      We try to implement the newest features of the software considering economic sensitivity analysis and economic modelling and further use the software in cooperation with our project partners for process evaluation

Final questions (Both)

       When you came to our user group forums, what did you enjoy the most?

       Peer effects of the entire BioSolve community for an overall continuous improvement of economic modelling

      What developments, changes or upgrades would you like to see in future versions of BioSolve Process?

       More ecological aspects

      What three words would you use to describe BioSolve Process? We would like to hear 3 each from both of you, please.

       Alois: Advanced process simulation
Alessandro: Sensitivity analysis assistance

      Thank you! Any last comments?

       Thank you!


1st published 05/11/ 2020; 2nd published 26/01/2021