Is single-use equipment vital for the industry?

IRUBIS is releasing a limited part series on interviews with experts in the field, to ask them tough questions in the field of bioprocessing.?Stay tuned to hear what they think about digitalization, expansion of continuous processes and more.

IRUBIS GmbH is biotech start-up and specialised in novel FTIR instruments "Monipa" specifically tailored for bioprocessing. Dr. Géraldine Baekelandt ("GB") worked as a Downstream Applications Manager at IRUBIS.

Alvotech?is a fully integrated specialty biopharmaceutical company focused on development and manufacturing of high-quality biosimilar medicines. Dr. Adrianna Milewska ("AM") is a Senior PAT Scientist at Alvotech in Reykjavik.

GB: Now onto a more equipment-based question, how important is single use equipment to you, is that an important part of looking at new technologies or not as much as we might think?

AM: I think it is important as the industry is going more into single use solutions. In the upstream processes, single use bioreactors are used that reduce the risk of cross-contamination and decrease the downtime between the runs. As for the downstream purification processes, single use solutions also reduce the risk of contamination and introduction of impurities, but most importantly, they enable us to adapt to the process, not vice versa. Flow cells used by PAT equipment, for example, can be easily customized to fit the given tubing diameter. Although it is easier to implement in the upstream process, it may be more complicated for the downstream as each step may use different size of tubing and different connections. Ultimately, it makes everything so much easier, if you can just connect the customized single-use consumable to your process, instead of figuring out how to connect different tubing sizes and connectors to prevent leaking and avoid pressure issues. Single-use solutions are also preferable for the scale up purposes and definitely for manufacturing, where high sterility is of the most importance.

GB: Okay, that's interesting. Do you also think that the downstream is lagging slightly behind upstream innovation?

AM: Yes, definitely. I see that it is lagging behind upstream with the implementation of real-time monitoring and single-use solutions, which are more difficult to be implemented in-line. But more importantly, downstream processing has not kept pace with the increases in the product titre resulting from intensified upstream process. With higher protein titres, the downstream faces challenges with increased impurities and formation of aggregates, so definitely new strategies need to be identified. For example, we can choose from a toolbox of new generation resins with higher dynamic binding capacities, membranes which enable higher flow rates, or multicolumn chromatography which allows more columns to be added to the process as the titre increases to try and match the downstream capacity with the upstream.

GB: That's really interesting to know from your perspective. So now the last question, is going to be a bit more focused on your job. What do you find the most fascinating part of your job?

AM: The most fascinating part of my job is that I get to work with different departments and different processes across the whole company. So I get a little bit of everything, a bit of upstream, a bit of downstream, a little bit of drug product development. I admire the process of implementing real-time spectroscopic solutions to different processes and demonstrating people how much more information they can get in so little time, as compared to offline analytical measurements. I also appreciate the collaboration with the experts in the given process on the implementation of the new technologies, as it provokes brainstorming and scientific discussions, which lead to new discoveries and potential applications. It is both challenging and motivating, which I really like about my job.

Thank you for reading our interview! What is your opinion, do you need more innovations in bioprocessing?