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Thermofisher unveils strategies for scaling up mRNA production to industrial volumes using Invitrogen Dynabeads magnetic bead technology and SEPMAG is one of its choices!!

 The growing field of mRNA-based therapy requires flexible and scalable tools for mRNA production and purification, so that the diagnosis and treatment of disease can be achieved at scales ranging from small scale production of personalized medicine, to large scale production of preventive medicine.   Within this context, a research team from Thermo Fisher Scientific, (formed by Marie Bosnes, Christopher Stensrud, Elisabeth Breivold, AusraKaleckiene, FraukeHenjes, Axl Neurauter and Lene Aasveen), have developed a mRNA purification protocol based on Invitrogen DynabeadsTM magnetic bead technology. 

Magnetic bead handling is flexible, scalable, and easy to automate, from high throughput small scale production to large production volumes in closed systems”

Free guide: 7 Keys to Successfully Scaling-up Biomagnetic Separation Processes

The research team demonstrated the successful direct scalability of mRNA synthesis and purification using the Solid-Phase in Vitro (IVTS) reaction. The scaling-up was achieved from 0.1mL to 300mL, with no changes in the yield/mL or RNA integrity. They featured that the linear increase in yield with volume-reaction makes feasible the direct scaling-up of the process up to liter volumes. The method presents additional advantages as it allows the re-cycling of of DNA template for IVTS up to 5 times, enabling the continuos flow principle for large scale production in small or large volumes. 

Among the different options (Bottles, bags or reactors), the researchers used a SEPMAG N2L for testing the process with bottles. These results were presented in the 8th international mRNA Health Conference [1]. 

The separation of batches up to 20 L of magnetic-beads suspensions is already a well-established technology for IVD-kits manufacturing. Using bottles and standard advanced biomagnetic separation systems, the separation processes are smoothly scaled up from milliliters to tens of liters. With customized systems, it is also possible to extend the range up to 50 L carboys.

[1] M. Bosnes, C. Stensrud, E. Breivold, A. Kaleckiene, F. Henjes, A. Neurauter, L. Aasveen Strategies for scaling up mRNA production to industrial volumes using Invitrogen DynabeadsTM magnetic bead technology” 2020, 8th International mRNA Health Conference.  

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Lluis M. Martínez | SEPMAG Chief Scientific Officer

Founder of SEPMAG, Lluis holds a PhD in Magnetic Materials by the UAB. He has conducted research at German and Spanish academic institutions. Having worked in companies in Ireland, USA and Spain, he has more than 20 years of experience applying magnetic materials and sensors to industrial products and processes. He has filed several international patents on the field and co-authored more than 20 scientific papers, most of them on the subject of magnetic particle movement.

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