Journey Through mRNA Production
MessengerRNA (mRNA) based vaccines have shown great success during COVID-19 pandemic as the two very first mRNA COVID-19 vaccines reached the global...
Contents
Streamlining the Upstream Workflow for Plasmid DNA Manufacturing
Learn More: Residual Host Cell DNA Quantitation
mRNA Synthesis and Optional Post-Transcriptional Modifications
The mRNA Therapeutic Boom
Plan for Success With Your Process Liquid and Buffer Preparation
Analytical Solutions for mRNA Vaccines and Therapeutics
Follow the path from mRNA encapsulation to mRNA drug product distribution
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MessengerRNA (mRNA) based vaccines have shown great success during COVID-19 pandemic as the two very first mRNA COVID-19 vaccines reached the global market in 2020. This success highlighted the advantages and potential of utilising in vitro transcribed mRNA molecules as vaccines against other viral infection diseases and oncology indications. In addition to vaccines, this mRNA technology can be applied in other therapeutic areas to cure diseases where the treatment requires the expression of specific therapeutics proteins such as protein replacement therapies, CRISPR/Cas gene editing systems and CAR T-cell therapies.
mRNA vaccines and therapeutic molecules can be categorised in three sub modalities: conventional non-replicating mRNA (with or without modified nucleotides), self- amplifying RNA (saRNA) and circular RNA (circRNA). One of the benefits of developing saRNA and circRNA as next generation therapeutic molecules is lower dose requirement and therefore lower cost per dose compared to conventional mRNA molecules.
Like many therapeutic manufacturing workflows, every step in the mRNA process builds upon the prior step. Plasmids are critical starting materials used for mRNA synthesis, after which the resulting purified mRNA is encapsulated for more efficient stability and delivery. The encapsulated final drug product must then be sterile filled, packaged, labelled, and shipped to its final clinical destination. Additionally, in-process and final release testing are critical to ensure robust Chemistry, Manufacturing, and Controls (CMC). As the manufacturing process progresses, every step adds complexity and cost, so it’s important to ensure steps are compatible and integrated into each other.
This ebook will cover the mRNA production journey starting from plasmid DNA production to final drug product shipping considerations. First, please hear from key opinion leaders from Wacker Chemie AG about their perspective on mRNA technology.
