Biopharm interview with Batavia Biosciences

General questions

       What is your name, company name and position?

       My name is Alfred Luitjens, I currently work as Director of Cell Technologies at Batavia Biosciences, a CDMO with extensive experience in vaccine, recombinant protein, monoclonal antibody and gene therapy projects.

       What is involved in your role?

       I manage the Upstream Processing (USP) team and a number of high profile projects that our multi-disciplinary team is engaged in.

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

       I’ve been using BioSolve Process for over 6 years, so I guess I’m a power user – my first experience was with version 3.

       Which version of BioSolve Process do you use currently?

I currently use BioSolve Process 7.0. I’ve been impressed with the acceleration in upgrades since version 5, especially the way we can manage formulas in the ‘Process’ sheet. Ribbon integration has been great too, although sometimes those ribbons disappear time to time.

Biopharm Services: Yes, we know about this issue and are planning a solution for the next release.

       What do you use BioSolve Process for?

       For example, in Batavia Biosciences’ project with the Bill & Melinda Gates Foundation, where we develop bioprocesses for a novel cost-effective rotavirus vaccine for the developing world, we are using BioSolve Process to predict whether the target price can be reached with the proposed process. A rigorous price reduction is needed to prevent the yearly 215,000 deaths of young children in low income countries due to rotavirus infection.

Also, BioSolve Process is a great process development tool – we use the software to determine what to focus on, as well as what not to focus on.

Biopharm Services: Interesting, can you expand on it?

We have been using BioSolve Process in process development projects. In one of these projects, the raw material was very expensive, and was therefore identified as a cost driver. However, by using BioSolve Process, we saw the overall effect of this raw material wasn’t really a cost driver. We were focusing in the incorrect area. In another case, we tried to remove some part of development from the process and saw no impact either before and after so this freed-up time to concentrate on more significant matters.

       What do you like most about BioSolve Process?

       In the past, I used Excel to perform cost calculations – applying all that I knew about the process and associated cost. However, by using BioSolve Process, I could see other cost categories that I needed to add – so it helped me to account for items that weren’t immediately obvious.

Within BioSolve Process, I did the calculation with existing products and the cost came-out quite close to the actual. Of course, this took time to configure, but once set-up correctly, BioSolve Process is a power tool.

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

       It took 4 to 6 weeks to fully understand the software. I needed to understand how to set it up for our organization; you need to know about the process to appreciate the true value.

However, when I had question, Biopharm Services provided very good support material with detailed explanations.

Another thing to mention is that it is based on an Excel framework, which is easy to understand but is also easy to make mistakes.

Biopharm Services: That is very interesting; how are you mitigating these mistakes?

Firstly, I continually sanity check my work to make sure that there aren’t any silly mistakes. Secondly, I talk to other colleagues and have positive critique session by reviewing outputs together – by doing so, we can see if the model I created makes sense or not. This is group support from my colleagues.

Biopharm Services: Thank you. We agree, peer review is very important. How do you deal with difficulties?

In 6 weeks, you can learn how to use tool. But to understand what is going on in the background takes longer.

The user guide is helpful but quite long and sometimes difficult to find what you are looking for.

It would be good to have quick learning tool capability for those difficult to find categories such as waste, energy and environmental monitoring; and how these are incorporated into BioSolve Process. 

About your organization and BioSolve Process

How does BioSolve Process currently create value in your department?

       Batavia Biosciences is currently using BioSolve Process in projects with the Bill & Melinda Gates Foundation. It is very helpful to demonstrate that the product price they want to achieve is possible based on the proposed process development plan. Batavia Biosciences focusses on scalable and cost-efficient process development and Clinical Trial Material production for Phase I and II studies.

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

       As part of Batavia Biosciences’ new initiatives, we are using BioSolve Process to create more value for our sponsors. With the software, we can accurately determine the effect of a development proposal on the Cost of Goods – making sure our sponsors get the optimal result out of their process development investment. Significant reductions in Cost of Goods paves the way to more affordable marketed medicines.

We use BioSolve Process to show how a small change in the process can impact the overall costs. For our sponsors, we first calculate the initial cost for their product; this way the sponsor sees where they stand and how much development is still needed to reach, for example, the desired Cost of Goods.

       Are there other areas of your company’s business that you feel could benefit from BioSolve Process? If so, which ones and why?

       It can benefit the tech transfer to the sponsor’s facility or a commercial scale CMO. It would provide them with sufficient information relating to the main process, CAPEX and OPEX. Of course, this needs to be supplemented by additional process description/batch records to support those data. Again, we need to use our heads when using software including BioSolve Process and check the results.

       Do you see BioSolve Process primarily as an internal or external communication tool?

       In the past, Batavia Biosciences used BioSolve Process as an internal communication tool for internal projects. But now, we are using it differently; as an external communication tool with sponsors. Both options are valuable and relevant.

Final questions

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

       There is a good function to export the data to PowerPoint, but the amount of information is quite limited.

It is great to have the Process Flow Diagram output in PowerPoint format. For example, Bioreactor with Support Systems. Further graphical representations would be good.

Also, it would be great if we could do more planning of processes with BioSolve Process being more of a scheduling/planning tool to address resource aspects such as labour allocation. This will make it easier for the non-BioSolve user to understand the results.

       What three words would you use to describe BioSolve Process?

       User-friendly, Relevant, Enlightening

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