Biopharm Services and McMaster University is kicking off the collaboration project to conduct Cell Therapy and Gene Therapy modelling together. Here is our interview with them.

Good morning to you, David. Would you kindly introduce yourself to our audience?

        I’m an Associate Professor in the Department of Chemical Engineering at McMaster University which has been ranked for the past four years as “the most research-intensive university” in the annual ranking of Canada’s top universities.

What type of research are you specializing in?

        My research group is working in the field of separation science and technologies, with a strong emphasis on membrane separation processes. One key segment of our research program is to ‘perfect’ the downstream purification platform for large-scale manufacturing of therapeutic viruses in order to simultaneously increase the yield and purity. Most of our work to date has been highly experimental in nature and done in collaboration with the manufacturing team at McMaster’s Fitzhenry Vector Laboratory, one of only two academic-based GMP suites in Canada for producing viral vectors.

Any publications that you can introduce us to get to know your projects better?

        We recently published a paper titled ‘Integrated development of enzymatic DNA digestion and membrane chromatography processes for the purification of therapeutic adenoviruses’ in Separation and Purification Technology; this was in a special issue associated with presentations made at the 2019 Biopartitioning and Purification (BPP) meeting. We’re also keenly interested in developing new sterile filtration membranes (as described in this paper published in Biotechnology and Bioengineering) and new sterile filtration processes (as described in this paper in the Journal of Membrane Science).

So can you tell us why you decided to collaborate with Biopharm Services?

        We sought out a collaboration with Biopharm Services primarily because of the emerging trend in the bio-processing community towards the adoption of modelling tools to determine ‘economic feasibility’ of manufacturing processes across different scales of operation.

What type of processes would you like to model with BioSolve Process?

        We are interested in modelling the entire downstream purification platform for various types of ‘therapeutic viruses’ for both oncolytic applications (e.g. adenovirus) and gene therapy applications (e.g. lentivirus). We are particularly interested in the implementation of membrane chromatography processes given their numerous advantages over traditional column chromatography for the purification of ‘large’ biomolecules.

What is the most exciting aspect of our collaboration together?

        Our collaboration with Biopharm Services is exciting for two reasons. The first is the potential to rapidly advance the bio-processing field via effective translation of information between academia and industry. The second is the opportunity to give students practical training in the use of ‘state of the art’ tools.

Thank you so much!

Now we would like to interview Karina (noted below as K) and Ian (noted below as I) – would you kindly introduce yourself?

        K: I’m a Ph.D. Candidate in Chemical Engineering at McMaster University (when the interview has been conducted in March 2021, Karina was still at McMaster University; she has now left and is employed elsewhere) co-supervised by Prof. David Latulippe and Prof. Raja Ghosh. For the past 3 and a half years I have been working on the development of processes for the purification of therapeutic viruses. Before this, I did my undergraduate in Bioprocess Engineering and Biotechnology at the Federal University of Parana in Brazil and spent a year working for a local biotech company.

Most of the work on the first half of my Ph.D. was focused on applying membrane chromatography for virus purification, involving a lot of experimental work related to all steps of virus production.

Now we are applying the collection of results and the knowledge acquired over the years to model and analyse the process using BioSolve Process and reach more rational conclusions when making process development decisions.

I: I am also a Ph.D. Student in Chemical Engineering and I am being supervised by Prof. Latulippe and Prof. Mhaskar at McMaster University. I began my Ph.D. in January of 2021.

My Ph.D. studies focus on developing mathematical models for the purpose of improving chromatography process development in the biopharmaceutical industry.

Before my Ph.D., I gained three years of experience in the manufacturing industry. My time in the industry was split between two companies. At one of these companies, I helped produce ultrafiltration systems that clean industrial wastewater for environmental discharge or water re-use. At the other company, where I spent almost two years of my time, I helped produce injectable pharmaceutical products at commercial and development scales.

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

        K: I have been using the software for almost two months now and I would consider myself an intermediate user.

That is because most of the work so far has been based on the modelling aspects, but the software also has powerful analysis tools that I can’t wait to use to analyse my full process soon.

I: I would classify myself as a beginner user of BioSolve Process.

Which version of BioSolve Process do you use currently?

        BioSolve Process 8.1

What do you like most about BioSolve Process so far?

        K: I like that it is based on Excel and so I can easily customize the model the way I need to. It is very flexible.

With that I can consider as much or as little detail as I want depending on the type of analysis I am doing.

I: I like the simple methods utilized to simulate many different production scenarios. Using BioSolve Process, it is easy to determine the impact parameters adjustments may have on the end-to-end manufacturing process costs.

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?

        K: The fact that it’s based on Excel makes it easy to learn if you are already comfortable with Excel.

At first it’s like moving to a new city, you are not sure where everything is but soon you become familiar with how the different tabs are organized and it starts to make sense.

Then you need to get familiar with the built-in functions, but it just needs a little practice.

The software comes with a few predefined process examples which are a great resource to look at when you are learning how to configure unit operations and so on.

Creating the model is not as visual as other software such as SuperPro Designer® or Aspen Plus® where you can create flow diagrams. But I think that the ease at which you can customize the unit operations just by knowing Excel compensates the visual aspect. There is no need to know programming languages to create an advanced model.

I: I found the BioSolve Process learning curve to be manageable for simulating the built-in processes. The training provided by Biopharm Services was very comprehensive and the BioSolve Process software reminded me of other process simulation tools. Although creating and simulating a new process requires some hands-on experience with the software, I think anybody with a basic understanding of Excel can learn how it is done.

Final questions

What three words would you use to describe BioSolve Process?

        Rational process development

When we conducted this interview in March 2021, we just started collaboration projects to establish generic Cell Therapy/Gene Therapy processes together. Watch out this space for the next interview with them!