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Adenovirus Vector Manufacturing Platform Using CIMmultus® QA Column to Produce Safer Products Cheaper

Adenovirus vector, a well-known gene therapy tool, vaccine vector and an oncolytic virus has recently regained attention during the global health crisis induced by Coronavirus. Their ability to induce a potent immune response is advantageous, and millions of doses have been administered worldwide with low rates of adverse effects observed [1]. Nonetheless, several serious thromboembolic events that were not correlated with mRNA-based vaccines have been described [1–5]. It has been indicated that the side effects could have been due to process-related impurities in the vaccines, such as host cell proteins [6] and DNA [5]. Regardless of the application, it is of the utmost importance to further improve the purity of the final product and reduce the possibility of potential side effects. In this work, we showcase a second-generation Adenovirus purification process based on CIMmultus® QA monolith chromatography (Figure 1). We additionally focus on bridging upstream and downstream using the newly developed PATfix® Adenovirus analytics, which allowed connection and enrichment of data obtained through commonly used methods such as ddPCR, total protein and infectivity assay.