Drivers of Change in Bioprocessing

To?all of?our readers, we’re delighted to have you back?for?our IRUBIS newsletter!

IRUBIS is releasing a limited-part series of interviews with experts in the field?where they?share their insights into the future of bioprocessing,?to let us know more about their career paths. This edition of the IRUBIS newsletter features the second part of our exciting interview with Dr. -Ing. Karl Rix , independent consultant and Advisory Board member at IRUBIS. Leading the conversation is Yaren Kars , an ambitious member of our IRUBIS marketing team with a passion for bioprocessing.?

??Let’s explore the last part of our interview!

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YK: In this rapidly advancing industry, your insights have been invaluable for our readers. As we explore further, we now would like to hear your perspective on the role and significance of single-use equipment. What are your thoughts on single-use equipment in bioprocessing? Do you believe its importance varies between upstream and downstream processing?

KR:?Single-use technologies are important tools in creating faster and more flexible bioprocessing production lines. Speed and flexibility are two major drivers for cost reduction, offsetting the (sometimes) more expensive single-use approach compared to reusable equipment.

Today single-use technologies are more prominent in upstream. However, “tomorrow” I see single-use technologies becoming more widely used in downstream.

YK: I definitely agree. At IRUBIS, we offer our biopharma customers single-use flow cells, which not only enhance flexibility and speed but also significantly prevent cross-contamination risks. Another significant trend is the shift towards continuous processing. What factors are driving the biopharmaceutical industry to explore continuous processing??

KR: About 20 years ago I attended an IFPAC conference and was amazed to hear that the US FDA was endorsing and promoting very heavily continuous bioprocessing. The main driver for the support by the FDA was the cost of drugs and their availability, true at the time and still true today.

YK: Clearly, the cost and availability of medicines are vital considerations. Hence, the shift towards continuous processing accelerates every day. As in every endeavor, there are certainly obstacles to overcome. From your perspective, where do you see the biggest challenges for continuous downstream processing?

KR:?There are significant technological and logistical challenges, but as an engineer, I feel those are manageable and there will be adequate solutions. From my point of view an equally, if not harder, challenge is the regulatory framework needed, e.g. how to release a batch to market in a continuous production setup. Today most regulatory protocols are focused on batchwise production processes.

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YK:?Addressing regulatory hurdles is indeed a complex action, especially for biopharmaceutical production processes. Given these challenges, what tools or new technologies would you recommend for addressing some of these challenges??

KR:?Automation and Process Analytical Technologies (PAT), such as Monipa, will contribute to establishing more continuous downstream processing. It may also help to compare notes with the food industry, which is facing similar challenges in the continuous manufacturing of food products.

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YK: Thank you for highlighting your insights on Monipa’s promising potential in bioprocessing. On a different note, we are also interested in hearing your perspective on innovative ventures. What is the aspect that you like most about start-up companies?

KR:?Simply, I love the culture and mindset of people in a start-up company, being enthusiastic and dedicated to success, the speed of tasks getting done and results being created, as well as the flexibility and the willingness to take risks. The larger the organization the slower the performance gets, and I am speaking of experience having worked in small start-ups and larger organizations.

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YK: I can absolutely tell that it resonates with our journey in IRUBIS as well. Having been immersed in the start-up environment for over a year, there is indeed a more vibrant atmosphere when compared to big-scale companies. Finally, just before we conclude our interview, what do you envision for the future of start-ups in the bioprocessing industry?

KR:?Start-ups continue to be needed by the bioprocessing industry to create true innovation. A lot of what we discussed above will only be achieved by or with the contributions of start-ups.

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We deeply appreciate Dr.-Ing. Karl F. Rix for sharing his expertise and insights with us. His perspectives are both inspiring and informative.? It is evident that innovation and collaboration will have a significant impact on shaping the future of the dynamic bioprocessing landscape. We aim to facilitate the revolution of the sector with our cutting-edge bioprocess monitoring technology, Monipa! ??

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