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2023 | September / October 2023

Removing Barriers to the Production of mRNA-Based Vaccines & Therapeutics

by cyb2025
J. Castillo
biotechnology
In vitro
Intensification
Manufacturing
mRNA vaccines
Purification

JOSÉ CASTILLO
CEO, Quantoom Biosciences (a Univercells company), Nivelles, Belgium

ABSTRACT

mRNA vaccine is the newest type of vaccine available to the public and has great prospects in terms of speed from research to market. In manufacturing, some barriers observed during Covid can already be lifted up such as (A) a slow transition from research to commercialisation, (B) unequal access to vaccines across countries and (C) inadequate supply of raw materials. Solutions have already been found for (A) a quicker shift from benchwork to commercialisation with a manufacturing process based on repeat-batch production of in vitro transcription (IVT), (B) technology that is small, straightforward to use, modular and transportable to diverse locations and (C) increased number of suppliers for critical raw materials, which are reputable for reliable and predictable deliveries. RNA production with Ntensify™ starts with DNA templates which are first transcribed into RNAs and then purified, ready for encapsulation. In this process, the reaction volume of the in vitro transcription (IVT) is fixed to 20 mL. Large-scale manufacturing occurs by 20 mL increment: i.e. repeat-batch production, with the benefit of an already optimal ratio for reagents (a process co-developed with our partner eTheRNA), which avoids dedicating time to optimisation when entering production. With both high yields and low impurities RNAs, purification can be simplified to a single step. To demonstrate that our approach in 20 mL is successful, several constructs were tested using this process. Their sequence length ranges from 1999 and 4060 ribonucleotides. mRNA reaction yield is on average 5.1 mg/mL. Analysis of the data shows that all batches met the specification limits, where defined.

OPINION ARTICLE
mRNA vaccines played a pivotal role in helping to bring the Covid-19 pandemic under control. Usually the development of vaccines takes several years, and sometimes even decades. But in as little as a year, several vaccines were developed against Covid including two mRNA vaccines (1-2). This unprecedented achievement highlights the great potential of this new class of medication. However, like other new products on the market, mRNA vaccines face multiple barriers in their development and production. While mRNA therapeutics are relatively quick to make they are difficult to scale up to commercial manufacture. Scale-up requires substantial optimisation which is very time-consuming.

ABOUT THE AUTHOR

José Castillo innovates in biopharmaceutical processes. Previous accomplishments include the start-up of Artelis, where he designed and developed bioreactors. iCellis is now considered the standard in the vaccines and gene therapy industry. In 2013, José co-founded Univercells to “make biologics available and affordable for all”. The goal is to disrupt the industry and offer comprehensive manufacturing solutions. In 2021, José launched Quantoom Biosciences, with the mission to remove the barriers to making mRNA-based vaccines & therapeutics, from sequence up to mass production.

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