Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland.
However, the firms plan to establish additional production suites across Lonza’s worldwide facilities. The aim is to make up to one billion doses of mRNA-1273 per year, assuming a dose of 50 µg.
Preliminary manufacturing work has begun in the United States, according to Lonza spokeswoman, Sanna Fowler.
“In July we started small-scale production at our Portsmouth, NH, site and are on track for the delivery of four suites for large-scale manufacturing. One of these will be in Portsmouth with a further three in our Ibex facility in Visp, Switzerland,” she says.
Moderna moved mRNA-1273 into Phase III trials in July. The NIH and the Biomedical Advanced Research and Development Authority (BARDA) are providing support as part of Operation Warp Speed.
Moderna’s mRNA vaccines comprise noncoding regions and variable sequences encoding the desired antigen. The firm says its candidates are faster to make than mAbs made from components produced in cells.
Another advantage—according to Moderna—is that mRNA synthesis is straightforward to automate.
Fowler tells GEN, Lonza will use synthesis processes developed by Moderna to scale up production of mRNA-1273.
“Lonza will be replicating Moderna’s core process design and scaling up to enable them to meet their goal of global supply,” notes Fowler. “This includes harnessing digital technology to ensure repetitive automated processing, paperless generation, review, and exchange of data.”
Demand for automation, digital manufacturing, and “bioprocess 4.0” ideas are increasing across the industry, continues Fowler.
“This is clearly a huge area and these technologies are becoming an integral part of all biomanufacturing processes. For example, our new 6,000 L facility in Portsmouth, NH, has been built with a strong focus on automation,” she says.
“We are implementing full-suite process analytic technology (PAT) and advanced multi-variate analysis (MVA) to ensure consistent performance.”
There are also clear benefits for CDMOs, Fowler says, explaining, “Having access to data not only enables us to improve efficiency but can also facilitate the regulatory approvals and gives our customers full visibility.”
Lonza is part of a cross-industry group led by Biophorum (BPOG) that aims to help drive “Bioprocess 4.0” forward. The firm contributed to the recently published manifesto on the quality control laboratory of the future.
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