• Antleron NV

Evan develops monitoring & control for cell-based processes to enable sustainable ATMP manufacturing

Meet Evan Claes. He is a KU Leuven bio-engineering graduate who joined Antleron in 2017 to investigate non-invasive process monitoring solutions for advanced therapy medicinal products (ATMPs). His in-depth research enabled Evan to pursue an industrial ‘Baekeland’ PhD at Antleron in collaboration with the Ghent University.

Advancing process monitoring for ATMPs

Evan Claes: "In 2019, I kicked off this challenging PhD journey which focuses on the development of 'soft sensors’ and next generation technologies for process monitoring in the ATMP industry."

The six-year PhD project on which Evan is working, received funding from the Baekeland PhD program of Flanders Innovation & Entrepreneurship (VLAIO). The Ghent University is actively involved as academic promotor through promotors Prof. Thomas De Beer and Prof. Jan Verwaeren, who are specialized in process analytical technology (PAT) and modeling & data analysis of biological systems, respectively.

"Antleron is heavily involved in ATMPs," explains Evan. "Our team of multidisciplinary specialists is developing and integrating technologies to enable next-generation ATMP processes, including advanced monitoring. For example, within a VLAIO project we developed, together with our partner QbD, Cell by Design® (CbD), a cloud-based software platform to enable ATMP stakeholders to adopt a quality-focused ATMP development process through risk-based process assessments." The insights guide science and data-driven decisions to meet all pre-defined critical quality attributes of the ATMP under development.

Evan is extensively working on process monitoring, which is essential for QbD-based process development. "Augmenting CbD with advanced analytical method and soft sensor development will strengthen the platform and fuel Antleron’s mission: bringing affordable and effective ATMP processes to the market."

His PhD project aims to overcome the problem that off-the-shelf analytical methods do not exist for automated, closed ATMP processes. There is broad consensus to dig deeper into advanced ‘direct’ methods (e.g. non-invasive spectroscopy and holographic imaging) and ‘indirect’ methods (e.g. soft sensors), each holding specific challenges to resolve.

Applying QbD to analytical methods

"The challenge with advanced ‘direct’ methods is that these require a custom optimization for each process, which is a complex task. As a solution, I am testing the potential of 'Analytical QbD', Quality-by-Design applied to analytical methods. In general, QbD is highly suitable for tackling the optimization of complex processes or methods."

The main hurdle with soft sensors (indirect method) is that these generally consist of a machine learning model. Typically, such models need huge amounts of training data to operate accurately. "In light of extremely expensive ATMP processes, which typically are not executed on a regular basis, I am taking a new approach. Currently I am investigating a new type of model - a hybrid mechanistic / machine learning mode - which requires much less training data."

"The synergy between the Ghent University and Antleron in the context of my PhD is quite inspiring. The Ghent University is known for its academic expertise and Antleron is perfectly suited to set up and execute experiments but also to assess promising solutions in an industrial R&D setting. Antleron's ecosystem of partners and customers offers excellent ATMP process innovation opportunities and challenges in this regard."

Putting time and effort in discovering new things

Before joining Antleron, Evan did his thesis on lactate-based control for tissue engineering bioreactors in the KU Leuven research group, which Jan Schrooten (now CEO Antleron) was coordinating at the time. After that, Evan worked some time for Pfizer. Ultimately, he returned to Antleron to further investigate and develop monitoring and control solutions for cell-based processes.

"My drive for discovering new things also influences my travel plans," says Evan. "After traveling Greece, Sweden and the Azores, I went on a jungle trekking in Indonesia. I like to discover nature and cultural landmarks as well as meet local people and learn about their living habits. Discovering new things is my mantra in life. New insights enable me to look at the world from a different perspective."

"In my free time, I enjoy going to a bar or music festival just as much as practicing sports, such as running and snowboarding. I also like to step out of my comfort zone by trying out something new, such as laser shooting or a new hobby.”