Al: Tremendous Potential to Transform Bioprocessing Efficiencies

The biopharmaceutical industry is witnessing unprecedented growth, with a surge in demand for vaccines, monoclonal antibodies mAbs), and advanced modalities including RNA therapeutics, mRNA vaccines, and cell and gene therapies CGTs).

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Bioprocessing requirements for advanced modalities are increasingly complex, time-consuming, and expensive, with challenges associated with scaling up and reproducibility. Manufacturing of these advanced biopharma products using microbial, or mammalian cell lines needs to be safe, reliable, and cost-effective to enable the production of industrial levels of therapeutics with the desired quality.

While bioprocessing technologies have advanced exponentially over the years, with a shift to digitisation, single-use systems, robust analytics, and near real-time product release enabled by in-line or at-line monitoring), enabling continuous manufacturing for traditional vaccines and mAbs, there is still a huge unmet need to replicate this for advanced modalities. It is therefore critical to optimise the cell culture conditions, upstream and downstream processes, and monitor and control the processes and product characteristics to improve yield, quality, and overall process efficiency. The COVID-19 pandemic has created a huge demand for scalable and rapid manufacture of mRNA vaccines and other vaccine formats, making it a strategic imperative to focus on high throughput, scalable, and cost-effective manufacture of such biomolecules.