"Current production processes for personalized cell and gene therapies are stretched to the limit," says Reinout, a seasoned cell therapy expert from Maastricht, The Netherlands. "A paradigm shift is required to make ATMP processes more robust, flexible and affordable. Antleron's superb multidisciplinary team naturally blends with my academic and industrial expertise. Together, we will tightly collaborate toward new higher-scale production approaches and methods to bring personalized therapies to patients more efficiently and affordably. Antleron CEO Jan Schrooten and I know each other for years, and we both knew that someday our paths would cross to realize our shared goal."
Common ground to overcome process upscaling challenges
Reinout Hesselink has a biological background. He started off studying a master in movement science at Maastricht University before doing his doctoral research on skeletal muscle damage. "As part of my research on culture and differentiation of skeletal muscle progenitor cells, I was confronted with scaling cell-based production for the first time."
Subsequently, in senior roles for PharmaCell (Lonza) and DCPrime, Reinout optimized production process development focused on scalability and sustainability. He also helped compiling ATMP regulatory filings for both early and late stage clinical trials for companies like DCPrime, Iovance and Orchard Therapeutics and managed cell and gene therapy contract manufacturing at BioNTech.
Jan Schrooten and Reinout Hesselink regularly ran into each other on conferences, or at KU Leuven where their paths had crossed before. Reinout: "The common thread through our careers is our strong belief in personalized therapies and our drive to overcome process upscaling challenges."
"Now the time is right to collaborate intensively to fundamentally enhance cell and gene therapies and upscale their production processes from early clinical to commercial products. This is essential to increase ATMP success rates, as time and cost from lab to patient needs to be reduced further. So far, the most successful ATMP projects only benefitted several thousands of patients."
Pushing technological advances toward custom bioreactors and digital automation
The key to successful process upscaling lies in removing hurdles which prevent process robustness, control and automation. "First of all, the translation from proven biological concepts to large-volume bioreactor-based manufacturing processes needs to be automated. It avoids massive amounts of manual work, and allows the process to be verifiable and adjustable in a flexible way."
Everything that happens across all different process steps needs to be automatically measured and collected for real-time process monitoring and adjustment. Continuous actuation of corrective measures keeps every link in the chain run within spec to ensure robust performance and high process quality.
Antleron is among the pioneers which are realizing this turnaround. "I am looking forward to join the Antleron specialists and their technology toolbox in tackling different challenges across multiple disciplines. When developing ATMP processes, Antleron applies an innovative combination of different tools. Computer simulations provide detailed information into those bioreactor concepts that are most promising. 3D printing comes into play for producing custom cell culture devices in suitable materials with proper surface treatments. A variety of sensor types (cell characteristics, nutrients, etc.) are required to adequately take and collect correct in-process measurements. Through soft sensing and machine learning, the sensor information can be applied in real-time data processing for quality control purposes. Combining these tools with risk-based process development is a promising route towards sustainable ATMP manufacturing."
"Over the years Antleron has made serious progress with Cell by Design® (CbD), a software product developed together with QbD. The CbD software enables organizations 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. Further down the clinical and industrial translation, we can apply a similar approach for quality control in production upscaling.
Momentum to further increase ATMP process efficiency
"Apart from their deep expertise and rich experience, everyone at Antleron is friendly, helpful and open minded. Rubbing shoulders with them on a regular basis, opens the momentum to further increase ATMP process efficiency. There are plenty of multidisciplinary challenges we can tackle together as well as with external parties such as customers, partners, and research organizations. Collaboration is beautiful because any joint achievement outreaches personal capabilities while everyone learns from one another."
Reinout likes that things move forward. Also in his free time, when he enjoys cycling. "I like to take my race bicycle and go for a ride or exploring off-road trails on my mountain bike. Cycling is workout for my body and relaxation for my mind."