Enhancing the production of RNA with continuous manufacturing

Biopharma companies traditionally rely on batch manufacturing, where intermittent steps produce a particular quantity of a drug. Despite processes being well-established, batch methods can lead to manufacturing bottlenecks, with production timelines potentially spanning weeks and prominent challenges arising when production is scaled.

 
As a result, the industry is moving towards continuous manufacturing as a solution, encouraged by the guidelines from the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and the U.S. Food and Drug Administration (FDA)^1-4. The global market for continuous manufacturing was estimated at $2.08 billion in 2023 and is expected to rise at a compound annual growth rate of 6.04% to reach $4.3 billion by 2035⁵. The biopharma industry’s interest in continuous processes is linked to their multiple benefits, including reduced waste, minimised labour needs and lower risks.

One component of manufacturing that continuous methods can significantly enhance is analytical testing. Quality is an essential component of development and manufacture that helps ensure a product meets the critical quality attributes (CQA) and is safe for patients.

When using batch methods, samples are collected throughout the process and assessed in a remote laboratory, meaning assay results can take days to receive. Harnessing continuous manufacturing allows for real-time analysis through inline, online and at-line process analytic technologies (PAT). Incorporating automation can enhance sampling efficiency and can significantly reduce analysis timelines to as little as a day. Machine learning (ML) and artificial intelligence (AI) can also be used to develop models, enabling real-time monitoring and control across the entire processing line.

The move to continuous manufacturing from established batch methods for traditional biologics like monoclonal antibodies will require significant investment. However, the design of continuous processes for newer therapeutic areas like RNA therapeutics, such as for mRNA vaccine production, enables the effective design of continuous manufacturing from the start.

 
To learn insights from our expert, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, about PAT, automation and real-time data analytics in continuous manufacturing, read the full article on page 18.

 
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References

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